FDA 510(k) Clearance & Regulatory Information

SciMed Scientific Equipment LLC manufactures and ships FDA 510(k) cleared medical devices from our San Jose, California facility. This page documents the regulatory status of our products.

✓ FDA 510(k) Cleared ✓ USP Class VI Medical-Grade Silicone ✓ Latex-free · BPA-free ✓ Made in USA ✓ HSA/FSA Eligible (HCPCS A4562)

Silicone Ring Pessaries — Primary Product Line

FDA Classification Class II medical device
FDA Product Code HHW (Pessary, vaginal, non-rubber)
FDA Regulation 21 CFR 884.3575
510(k) Clearance Pathway Substantial equivalence to predicate silicone pessary devices
HCPCS Reimbursement Code A4562 (Pessary, non-rubber, any type) — HSA/FSA eligible
Material USP Class VI medical-grade silicone, latex-free, BPA-free
Manufacturing Site SciMed Scientific Equipment LLC, 4607 Black River Ct, San Jose, CA 95136, USA
Intended Use Non-surgical management of pelvic organ prolapse (POP) and stress urinary incontinence (SUI)
Prescription Status Non-prescription (Class II general-controls, available direct-to-patient in the US)

Other FDA-Regulated Medical Devices in Our Catalog

SciMed also supplies the following FDA-regulated medical devices. Specific 510(k) numbers and regulatory references are provided on each product page or on request from our clinical team.

  • Cryogun / Cryosurgical Instruments — FDA Class II, Product Code GEH (Cryosurgical instrument, cardiovascular / dermatologic / otolaryngologic)
  • Fluorescein Sodium Ophthalmic Strips — FDA Class II, 1 mg USP, Product Code HRT (Ophthalmic diagnostic drug)
  • Portable Vein Finder (SSE07) — Class I general-controls, non-emissive visible/near-infrared illumination; 510(k) not required under 21 CFR 876.1500
  • Wireless Binocular Indirect Ophthalmoscope — FDA Class II, Product Code HLI (Ophthalmoscope, direct)
  • ENT / Dental / Surgical LED Headlight — FDA Class I general-controls (illumination device)
  • Kiwi Complete Vacuum Delivery System — FDA Class II obstetric vacuum extractor

Requesting Regulatory Documentation

For hospital procurement, group purchasing organization (GPO) due diligence, or institutional review, we can provide the following documentation on written request:

  • FDA 510(k) clearance letter (specific K-number per product)
  • FDA Establishment Registration and Device Listing
  • USP Class VI silicone biocompatibility certification
  • Material Safety Data Sheets (MSDS) where applicable
  • ISO 13485 facility documentation (manufacturing partners)
  • Hospital / clinic purchase order terms (Net-30 available for verified institutional accounts)

To request documentation: Email sales@scimedstore.com with your institution name, department, and intended use. Our clinical team responds within one business day.

HSA / FSA Reimbursement

All SciMed pessary products are HSA/FSA eligible under HCPCS code A4562 (Pessary, non-rubber, any type). You can:

  • Pay directly at checkout with your HSA/FSA card (accepted during cart)
  • Submit the receipt for post-purchase reimbursement
  • Request a Letter of Medical Necessity (LMN) template at /pages/pessary-hsa-fsa-lmn-template

Medicare and Insurance Coverage

SciMed is not a Medicare-enrolled DME supplier. Purchases from SciMed are not reimbursable through traditional Medicare. Medicare coverage of pessaries requires:

  • A prescription from a Medicare-enrolled provider
  • Fulfillment through a Medicare-enrolled DME supplier
  • Billing under HCPCS A4562

For patients with HSA/FSA, direct purchase from SciMed is typically faster and significantly less expensive than clinic-dispensed pessaries ($49.99 direct vs $80-$180 at clinics).

Adverse Event Reporting

If you experience an adverse event related to a SciMed medical device, please:

  1. Contact your healthcare provider immediately for medical concerns
  2. Report to SciMed Clinical Team at sales@scimedstore.com or +1-669-265-9353 for product-specific documentation
  3. Report to the FDA MedWatch program at fda.gov/safety/medwatch

Procurement & Clinical Documentation

Hospitals, clinics, residency programs, and group practices can request full regulatory documentation packets, FDA clearance letters, and Net-30 institutional pricing from our clinical team.

Email sales@scimedstore.com or WhatsApp +1 (669) 265-9353

SciMed Scientific Equipment LLC · 4607 Black River Ct, San Jose, CA 95136 USA · Last updated: 2026-10-28