SciMed Ring Pessary — Instructions for Use (IFU)
SciMed Ring Pessary — Instructions for Use (IFU)
Full clinical instructions for inserting, wearing, cleaning, and caring for your SciMed Silicone Ring Pessary. FDA Class II 510(k) cleared medical device, manufactured in San Jose, California.
FDA 510(k) CLEAREDUSP CLASS VI SILICONEMADE IN USAREUSABLE 1–2 YRSHSA/FSA ELIGIBLE
📺 Watch: How to Use Your SciMed Ring Pessary
~90-second visual guide covering insertion, removal, weekly cleaning, and when to contact your provider. Best viewed full-screen on mobile.
Device Information
| Device | Silicone Ring Pessary (with or without Support Membrane); Knobbed Ring variant available |
| FDA Classification | Class II, 510(k) Cleared |
| FDA Product Code | HHN — Pessary, vaginal |
| 21 CFR | 884.5350 |
| HCPCS Code | A4561 — Pessary, rubber, any type (HSA/FSA eligible) |
| ICD-10 Indications | N81.0–N81.9 (genital prolapse) |
| Material | Medical-grade silicone (USP Class VI), latex-free, BPA-free |
| Sizes | 0–9 (44–102 mm outer diameter) — fit by clinical examination |
| Reusability | 1–2 years with proper care; autoclavable for clinical reuse |
| Manufacturer | SciMed Scientific Equipment LLC, 163 Silcreek Drive, San Jose, CA 95133, USA |
About Your Device
The SciMed Ring Pessary is a non-surgical device used to support the vaginal walls in cases of pelvic organ prolapse (POP). It is one of the most commonly prescribed pessaries worldwide and is recommended by ACOG Practice Bulletin No. 214 (Nov 2019) as first-line non-surgical treatment for symptomatic pelvic organ prolapse.
- With Support version includes an integrated membrane providing additional bladder neck support — preferred for patients with coexisting stress urinary incontinence or cystocele.
- Without Support version is an open ring designed for prolapse alone — the standard first-line choice.
- Knobbed version has a removal aid (~10mm soft silicone protrusion) for patients with arthritis or limited finger dexterity.
Before first use: This device should be fitted by a qualified gynecologist or urogynecologist. Confirm your correct size and type before insertion. If you are using a pessary for the first time, please confirm with your provider: your correct size, whether the with-support or without-support type is right for you, and any contraindications based on your medical history.
Indications for Use
- Stage I–II uterine or vaginal vault prolapse
- Coexisting mild to moderate cystocele (with-support version)
- Stress urinary incontinence (off-label, per provider judgement)
- Patients seeking non-surgical management of prolapse
- Bridging therapy pre- or post-surgical repair
- Self-managed daily pessary therapy
Contraindications
Do not use the SciMed Ring Pessary if you have:
- Active vaginal or pelvic infection
- Severe vaginal atrophy without estrogen therapy
- Active or untreated cervical/vaginal cancer
- Inability to insert, remove, or maintain personal hygiene
- Pregnancy (consult your provider for specific guidance)
Insertion (Step-by-Step)
- Wash hands thoroughly with soap and warm water.
- Empty bladder if comfortable.
- Apply a small amount of water-based lubricant to the ring and to your finger.
- Fold the ring in half — pinch the edges together so the ring forms a narrow shape.
- Choose a comfortable position: standing with one leg elevated (foot on toilet seat), squatting, or lying down.
- Insert the folded ring gently into the vagina, pointing toward your lower back. The vaginal canal angles backward, not upward.
- Push gently until the ring is past the pubic bone.
- Release the fold — let the ring open inside.
- Use your finger to position the front edge of the ring behind your pubic bone. It should rest there comfortably.
- Stand and walk a few steps. The ring should stay in place. If it feels uncomfortable or descends with light effort, the size may not be correct — contact your provider or email sales@scimedstore.com.
📺 Prefer to watch? See the video guide above for a visual walkthrough of insertion, removal, and care. Detailed written guide: How to Insert a Ring Pessary. Still unsure? Email sales@scimedstore.com or WhatsApp +1 (669) 265-9353 — our SciMed clinical team responds to every sizing question, same business day.
Removal
- Wash hands thoroughly.
- Empty bladder if needed.
- Insert a clean finger into the vagina and feel for the front edge of the ring (just behind the pubic bone). For Knobbed versions, feel for the removal knob.
- Hook your finger around the front edge of the ring (or knob).
- Gently pull the ring forward and down until you can fold and remove it.
Daily Wear
- Your ring pessary may be worn continuously for daily activity, including exercise.
- Some patients prefer to remove their pessary at night; others wear it 24/7. Follow your provider's recommendation.
- The Without Support ring can usually be worn during intercourse — the open center allows penetration.
- The With Support ring generally cannot be worn during intercourse — the support membrane interferes with penetration. Remove before intercourse and reinsert afterward.
Cleaning (Weekly Minimum)
- Remove the pessary.
- Wash with warm water and mild, unscented soap.
- Rinse thoroughly with clean water.
- Air dry or pat dry with a clean cloth.
- Reinsert.
DO NOT use these on your pessary: alcohol or alcohol-based wipes · petroleum-based products · bleach or harsh disinfectants · hot water above 60°C (140°F) · abrasive scrubbing pads.
Sterilization (For Clinical Reuse)
The device may be steam autoclaved at 134°C (273°F) for 18 minutes minimum. Do not exceed 138°C. After 50–100 autoclave cycles, inspect each device for surface degradation; replace devices that show wear. Steam autoclave only — do not boil, microwave, or chemical-sterilize.
When to Contact Your Provider
Contact your gynecologist, urogynecologist, or primary care provider promptly if you experience:
- Pain or discomfort that does not resolve with repositioning
- Unusual or foul-smelling vaginal discharge
- Vaginal bleeding (not menstrual)
- Difficulty urinating or having a bowel movement
- Sores or irritation in the vaginal walls
- Pessary repeatedly falls out (size may be wrong)
- Difficulty removing the pessary
- Symptoms of urinary tract infection (burning, frequency, urgency)
Sizing questions before contacting your provider? Our SciMed clinical team responds to every sizing question, same business day. Email sales@scimedstore.com or WhatsApp +1 (669) 265-9353. We will guide you through size adjustments and exchanges on unopened devices within 30 days.
Storage
- Store at room temperature (15–25°C / 59–77°F)
- Keep in original pouch when not in use, OR in a clean, dry container
- Protect from direct sunlight
- Do not refrigerate or freeze
- Replace every 1–2 years with normal use
Disposal
When replacing your pessary, dispose of the old device in regular household waste. The device is medical-grade silicone and is not hazardous.
Sizing or fit questions? Reach our clinical team directly
— The SciMed Team. Our clinical support team responds to every sizing question, same business day.
What's in Your Shipment
Every SciMed Ring Pessary ships from our San Jose, California facility with:
- ✅ Tamper-evident sealed pouch — medical-grade sterilized, with size, lot, and expiry markings
- ✅ Printed Instructions for Use (IFU) — folded inside the pouch
- ✅ Thank-you card from the SciMed team with company details and direct contact channels
- ✅ QR code on the thank-you card linking to this digital IFU page (you're here)
- ✅ Plain discreet outer carton — no clinical labelling, ships as "SciMed Store"
Missing documentation? If your shipment arrived without the printed IFU, thank-you card, or QR reference, email sales@scimedstore.com with your order number and we will send replacement documentation by email within one business day. If you purchased your SciMed device through eBay or another reseller, the reseller's packaging may differ from our direct shipments — email us anyway and we will send full IFU and certification documentation.
SciMed Scientific Equipment LLC · 163 Silcreek Drive, San Jose, CA 95133 · scimedstore.com
FDA 510(k) cleared as Class II medical device under FDA Product Code HHN, regulated under 21 CFR 884.5350.
ICD-10 indications: N81.0–N81.9 (genital prolapse) · HCPCS reimbursement code: A4561 (HSA/FSA eligible).
This IFU was last reviewed and revised on 2026-06-17. For the most current version, visit scimedstore.com/pages/pessary-ifu.
For sizing or fit questions, contact: sales@scimedstore.com or WhatsApp +1 (669) 265-9353.
FDA 510(k) cleared as Class II medical device under FDA Product Code HHN, regulated under 21 CFR 884.5350.
ICD-10 indications: N81.0–N81.9 (genital prolapse) · HCPCS reimbursement code: A4561 (HSA/FSA eligible).
This IFU was last reviewed and revised on 2026-06-17. For the most current version, visit scimedstore.com/pages/pessary-ifu.
For sizing or fit questions, contact: sales@scimedstore.com or WhatsApp +1 (669) 265-9353.