Device class
Class II
Regulation 884.5300
Total clearances
8
2022-02-25 → 2026-03-30
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.5300
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| A4261 |
HCPCS
|
Cervical cap for contraceptive use ✓ CMS-verified description |
High
|
Condom catheter (reusable), each |
Pulse
Most recent 510(k) clearances