Device class
—
Regulation —
Total clearances
7
2024-03-06 → 2026-01-20
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Cosm Medical |
1 |
0 |
2024-03-06 |
|
Reia, LLC |
1 |
0 |
2024-05-21 |
|
Resilia, Inc. |
1 |
0 |
2024-04-03 |
|
Watkins-Conti Products, Inc. |
1 |
0 |
2024-05-17 |
|
CooperSurgical, Inc.
|
1 |
0 |
2025-04-11 |
|
Cntrl+, Inc. |
1 |
0 |
2024-12-17 |
|
Cooper Surgical |
1 |
1 |
2026-01-20 |
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 |
| 57160 |
CPT
|
— |
Medium
|
Fitting and insertion of pessary; vaginal pessary is the primary device |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-01-20 |
K253698 |
Cooper Surgical
|
Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes |
| 2025-04-11 |
K250438 |
CooperSurgical, Inc.
|
CooperSurgical Milex® Pessaries |
| 2024-12-17 |
K240798 |
Cntrl+, Inc.
|
Cntrl+ Bladder Support Pessary |
| 2024-05-21 |
K232677 |
Reia, LLC
|
Reia pessary |
| 2024-05-17 |
K232525 |
Watkins-Conti Products, Inc.
|
Yoni.Fit Bladder Support |
| 2024-04-03 |
K233548 |
Resilia, Inc.
|
Uresta® |
| 2024-03-06 |
K231786 |
Cosm Medical
|
Gynethotics Pessary |