Uterine Aspiration Set
FDA 510(k) K251882 · Gcmedica Enterprise Ltd.(Wuxi)
510(k) numberK251882
Submission
- Device name
- Uterine Aspiration Set
- Applicant
- Gcmedica Enterprise Ltd.(Wuxi)
Wuxi, CN - Received
- June 20, 2025
- Decision date
- October 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HHK – Curette, Suction, Endometrial (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1175
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HHK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240434 | RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)HHK · Traditional | Li Medical Corporation , Ltd. | 09/25/2024SE |
| K201952 | CrossGlide ETS PlusHHK · Special | Crossbay Medical | 08/05/2020SE |
| K192534 | CrossBay Endometrial Tissue Sampler (ETS)HHK · Traditional | Crossbay Medical | 03/25/2020SE |
| K102847 | Disposable Endometrial Suction CuretteHHK · Traditional | Jiangsu Suyun Medical Materials Co., Ltd. | 04/14/2011SE |
| K092982 | The Panpac Suction CuretteHHK · Traditional | Panpac Medical Corporation | 07/26/2010SE |
| K051294 | Femtest Endometrial Suction Curette, Model FT-1HHK · Traditional | Femspec LLC | 12/21/2005SE |
| K040189 | Endometrial Sampling SyringeHHK · Traditional | Rocket Medical Plc | 10/04/2004SE |
| K021876 | Mas with or Without SyringeHHK · Traditional | Marina Medical Instruments, Inc. | 04/08/2003SE |
| K020628 | Curelle, Preferred Curelle, Cuteq 2.5HHK · Traditional | Bioteque America, Inc. | 05/24/2002SE |
| K001555 | Suresample-Wallace Endometrial Sampler, Endo 26HHK · Traditional | Sims Portex , Ltd. | 08/02/2000SE |
More from Sims Portex , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K182819 | Decanting DeviceLHI · Traditional | 12/02/2019SE |
Questions and answers
When was Uterine Aspiration Set cleared by the FDA?
Uterine Aspiration Set (K251882) received a 510(k) decision of Substantially Equivalent on October 16, 2025, 118 days after the submission was received.
What is the product code of K251882?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.