Device class
Class II
Regulation 884.1175
Total clearances
4
2020-03-25 → 2025-10-16
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.1175
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Crossbay Medical |
2 |
0 |
2020-08-05 |
|
Li Medical Corporation , Ltd.
|
1 |
0 |
2024-09-25 |
|
Gcmedica Enterprise Ltd.(Wuxi) |
1 |
1 |
2025-10-16 |
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 |
| 58120 |
CPT
|
— |
High
|
Endometrial biopsy or curettage procedure; suction curette is standard instrument |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-10-16 |
K251882 |
Gcmedica Enterprise Ltd.(Wuxi)
|
Uterine Aspiration Set |
| 2024-09-25 |
K240434 |
Li Medical Corporation , Ltd.
|
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) |
| 2020-08-05 |
K201952 |
Crossbay Medical
|
CrossGlide ETS Plus |
| 2020-03-25 |
K192534 |
Crossbay Medical
|
CrossBay Endometrial Tissue Sampler (ETS) |