Suresample, Endometrial Sampler

4 catalogue numbers from 3121, listed by Gynex Corporation, United States, under Curette, Suction, Endometrial (And Accessories). 4 manufacturers in China are registered for this product code.

Registry build 21.09.26
4manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HHK
Manufacturer City Province Registered as Device types
Zhejiang Shuyou Surgical Instrument Co., Ltd. Huzhou Zhejiang Contract manufacturer 13
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Jiangsu Suyun Medical Materials Co., Ltd. Lianyungang Jiangsu Contract manufacturer 11
Yangzhong Meidi Medical Products Co., Ltd. Yangzhong Jiangsu Contract manufacturer 3

Record

Regulatory record for Suresample, Endometrial Sampler
Listed by Gynex Corporation, United States
FDA product code HHK
Device type Curette, Suction, Endometrial (And Accessories)
Device class Class 2
Regulation 21 CFR 884.1175
Establishment Repacker / relabeller
510(k) K001555
Record published 2016-10-10
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Suresample, Endometrial Sampler
Catalogue number Size Per pack Status
3121 100 In distribution
3105 5 In distribution
3115 25 In distribution
3120 50 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cannula-Curette Coopersurgical, Inc. 25
Berkeley Vacurette Gyrus Acmi, Inc. 22
Rigid Uterine Aspiration Curette Gcmedica Enterprise Ltd.(Wuxi) 18
Tis-U-Trap Uterine Suction Curette Set Coopersurgical, Inc. 17
Cannula-Curette with 60cc Handyvak Syringe Coopersurgical, Inc. 11
Gyrus Acmi Gyrus Acmi, Inc. 7
Curette, Suction, Endometrial (And Accessories) Panpac Medical Corporation 6
Bioteque Bioteque Taiwan Ltd. 5
Flexible Uterine Aspiration Curette Gcmedica Enterprise Ltd.(Wuxi) 5
Pioneer IVF® LifeGlobal Group, LLC 4
Integra® Miltex® Integra LifeSciences Production Corporation 3
LTL Medical Bioteque Taiwan Ltd. 3

Showing 12 of 43. All products under Curette, Suction, Endometrial (And Accessories)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer