Curette, Suction, Endometrial (And Accessories)
FDA product code HHK · Class II (moderate risk) · 21 CFR 884.1175 · Obstetrics/Gynecology
42510(k) clearances
0PMA approvals
3recalls
Manufacturers
- American Hospital Supply Corp. 2
- Select Medical Systems, Inc. 2
- Ri Mos. S.R.L. 2
- Crossbay Medical 2
- Pioneer Medical, Inc. 2
- Milex Products, Inc. 2
- Sherwood Medical Co. 1
- Codman & Shurtleff, Inc. 1
- Sherwood Medical Industries 1
- Gynemetrics, Inc. 1
- Medi-Spec 1
- Berkeley Medevices 1
- Weston, Copco, Inc. 1
- Unimar, Inc. 1
- Gyneco, Inc. 1
- Zinnanti Surgical Instruments, Inc. 1
- Gcmedica Enterprise Ltd.(Wuxi) 1
- Laboratoire Ccd C/O Washington Regulatory Services 1
- Vista Products, Inc. 1
- Smithkline Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251882 | Uterine Aspiration SetHHK · Traditional | Gcmedica Enterprise Ltd.(Wuxi) | 10/16/2025SE |
| 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 |
| K001545 | Pipet CuretHHK · Special | Milex Products, Inc. | 06/15/2000SE |
| K000974 | Fowler Endocurette, Model Cur-XxxHHK · Traditional | Utah Medical Products, Inc. | 05/23/2000SE |
| K000026 | Apple Medical One-Touch Uterine SamplerHHK · Traditional | Apple Medical Corp. | 03/31/2000SE |
| K992926 | Ginram Endocic Single Oval Port (Model No. 720195)HHK · Traditional | Ri Mos. S.R.L. | 10/26/1999SE |
| K991895 | Rampipella, Singe Port (720196) & Wedge-Shaped Port (720217)HHK · Traditional | Ri Mos. S.R.L. | 08/12/1999SE |
| K990387 | Endometrial SamplerHHK · Traditional | U.A. Medical Products, Inc. | 04/20/1999SE |
| K974819 | Selectcells(Tm) MiniHHK · Traditional | Select Medical Systems, Inc. | 03/23/1998SE |
| K960239 | CPR D & C TrayHHK · Traditional | Custom Pack Reliability | 05/23/1996SE |
| K954097 | Selectcells StandardHHK · Traditional | Select Medical Systems, Inc. | 11/21/1995SE |
| K952652 | Medscand Endorette Endometrial SamplerHHK · Traditional | Medscand (Usa), Inc. | 09/15/1995SE |
| K915491 | CurelleHHK · Traditional | Bioteque Corp. | 11/04/1992SE |
| K914241 | Pioneer Pro-Pump Dual ControlHHK · Traditional | Pioneer Medical, Inc. | 03/04/1992SE |
| K914220 | Pioneer Pro-PumpHHK · Traditional | Pioneer Medical, Inc. | 03/04/1992SE |
| K881456 | Pipelle de Cornier Endometrial Suction CuretteHHK · Traditional | Laboratoire Ccd C/O Washington Regulatory Services | 10/14/1988SE |
| K875084 | Cabot Medical Endometrial Suction CuretteHHK · Traditional | Cabot Medical Corp. | 02/08/1988SE |
| K872908 | Endometrial SamplerHHK · Traditional | Zinnanti Surgical Instruments, Inc. | 10/20/1987SE |
| K853216 | Master Endomet Biopsy Kit W/Plas Cure 3,4MM-4003,4HHK · Traditional | Gyneco, Inc. | 04/02/1986SE |
| K854415 | Endometrial PipelleHHK · Traditional | Unimar, Inc. | 03/13/1986SE |
| K823080 | VakutageHHK · Traditional | Weston, Copco, Inc. | 11/24/1982SE |
| K823006 | Medevices Aspiration HoseHHK · Traditional | Berkeley Medevices | 11/04/1982SE |
| K822382 | U.V.A.C. Handler SetHHK · Traditional | American Hospital Supply Corp. | 08/25/1982SE |
| K812426 | Uterine Aspiration Curettes(Rigid&Flex)HHK · Traditional | Medi-Spec | 10/08/1981SE |
| K803210 | Menstrual Aspiration KitsHHK · Traditional | Gynemetrics, Inc. | 01/28/1981SE |
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | Sherwood Medical Industries | 07/21/1980SE |
| K791765 | Masterson* Endometrial Biopsy KitHHK · Traditional | Codman & Shurtleff, Inc. | 11/05/1979SE |
| K790875 | Monoject Endometrial Sampling KitHHK · Traditional | Sherwood Medical Co. | 07/30/1979SE |
| K781830 | Biopsy Kit 781101, AspirationHHK · Traditional | Vista Products, Inc. | 11/15/1978SE |
| K772121 | Aspirator & Probe, Cytology, Endomet.HHK · Traditional | Smithkline Diagnostics, Inc. | 11/17/1977SE |
| K771149 | Endometrial Aspiration Biospy Kit 182341HHK · Traditional | C.R. Bard, Inc. | 07/27/1977SE |
| K770674 | Curette, Uterine, Vacuum AspiratingHHK · Traditional | American Hospital Supply Corp. | 04/26/1977SE |
| K760264 | Curette, Proposed Tis-U-Trap, MetalHHK · Traditional | Milex Products, Inc. | 10/06/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0078-2023 Class II | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of…Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories… | Olympus Corporation of the Americas | 09/16/2022Open, Classified |
| Z-0488-2015 Class III | Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION…The product has been identified to contain an incorrect curette type. | CooperSurgical, Inc. | 10/27/2014Terminated |
| Z-0533-2015 Class II | An endometrial suction curette is a device used to remove material from the uterus and…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |