Data / Medical devices / Curette, Suction, Endometrial (And Accessories)
Curette, Suction, Endometrial (And Accessories) (HHK): 25 FDA-registered makers in 6 countries
25 establishments in 6 countries are registered with the FDA to make Curette, Suction, Endometrial (And Accessories) (product code HHK, Class 2, 21 CFR 884.1175). 13 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 42 510(k) clearances under this code, the latest on October 16, 2025, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HHK
- Device class
- 2
- Regulation
- 884.1175
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| China | 4 |
| Taiwan | 3 |
| France | 2 |
| Mexico | 2 |
| Belgium | 1 |
Makers of Curette, Suction, Endometrial (And Accessories)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 7 | June 15, 2000 | 0 | 1 | 0 | api.fda.gov |
| LifeGlobal Group, LLC | Trumbull, CT, United States | Specification developer | 2 | March 4, 1992 | 0 | 0 | 0 | api.fda.gov |
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer | 2 | April 20, 1999 | 0 | 0 | 0 | api.fda.gov |
| Bioteque Taiwan Ltd. | Xizhi Dist., New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | July 26, 2010 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | August 25, 1982 | 0 | 0 | 0 | api.fda.gov |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Manufacturer | 1 | October 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang Jiangsu, China | Manufacturer | 1 | April 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| Laboratoire CCD | PARIS Ile-de-France, France | Specification developer | 1 | October 14, 1988 | 0 | 0 | 0 | api.fda.gov |
| Li Medical Corporation Ltd. | New Taipei City, Taiwan | Foreign private label distributor, Manufacturer | 1 | September 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Quiroproductos de Cuauhtemoc S. De R.L. de C.V. | Cuauhtemoc Chihuahua, Mexico | Manufacturer | 1 | August 25, 1982 | 0 | 0 | 0 | api.fda.gov |
| Titus Medical LLC | Rock Hill, SC, United States | Manufacturer | 1 | April 20, 1999 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | May 23, 2000 | 0 | 0 | 0 | api.fda.gov |
| Zinnanti Surgical Design Group Inc | Santa Cruz, CA, United States | Specification developer | 1 | October 20, 1987 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioncise NV | Wellen Limburg, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prodimed | NEUILLY-EN-THELLE Oise, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Hospital Supply Co., Ltd | Tongluo Township Miaoli, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Womancare Global | Salem, VA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhong Meidi Medical Products Co., Ltd. | Yangzhong City Jiangsu, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Shuyou Surgical Instrument Co., Ltd | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.