Submission Details
| 510(k) Number | K251882 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2025 |
| Decision Date | October 16, 2025 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
Uterine Aspiration Set
Oct 2025
Decision
118d
Days
Class 2
Risk
About This 510(k) Submission
K251882 is an FDA 510(k) clearance for the Uterine Aspiration Set, a Curette, Suction, Endometrial (and Accessories) (Class II — Special Controls, product code HHK), submitted by Gcmedica Enterprise Ltd.(Wuxi) (Wuxi, CN). The FDA issued a Cleared decision on October 16, 2025, 118 days after receiving the submission on June 20, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1175.
Device Classification
| Product Code | HHK — Curette, Suction, Endometrial (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1175 |
Manufacturer
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