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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

CountryMakers
United States13
China4
Taiwan3
France2
Mexico2
Belgium1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer7June 15, 2000010api.fda.gov
LifeGlobal Group, LLCTrumbull, CT, United StatesSpecification developer2March 4, 1992000api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer2April 20, 1999000api.fda.gov
Bioteque Taiwan Ltd.Xizhi Dist., New Taipei City, TaiwanExporter to the US, Manufacturer1July 26, 2010000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1August 25, 1982000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaManufacturer1October 16, 2025000api.fda.gov
Jiangsu Suyun Medical Materials Co., Ltd.Lianyungang Jiangsu, ChinaManufacturer1April 14, 2011000api.fda.gov
Laboratoire CCDPARIS Ile-de-France, FranceSpecification developer1October 14, 1988000api.fda.gov
Li Medical Corporation Ltd.New Taipei City, TaiwanForeign private label distributor, Manufacturer1September 25, 2024000api.fda.gov
Quiroproductos de Cuauhtemoc S. De R.L. de C.V.Cuauhtemoc Chihuahua, MexicoManufacturer1August 25, 1982000api.fda.gov
Titus Medical LLCRock Hill, SC, United StatesManufacturer1April 20, 1999000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1May 23, 2000000api.fda.gov
Zinnanti Surgical Design Group IncSanta Cruz, CA, United StatesSpecification developer1October 20, 1987000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Bioncise NVWellen Limburg, BelgiumManufacturer0000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
ProdimedNEUILLY-EN-THELLE Oise, FranceContract manufacturer0000api.fda.gov
Pacific Hospital Supply Co., LtdTongluo Township Miaoli, TaiwanContract manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Womancare GlobalSalem, VA, United StatesSpecification developer0000api.fda.gov
Yangzhong Meidi Medical Products Co., Ltd.Yangzhong City Jiangsu, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Zhejiang Shuyou Surgical Instrument Co., LtdHuzhou Zhejiang, ChinaContract manufacturer0000api.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.