GEN2

Kevourkian Younge Curette, W/O Basket, Rigid Shaft, 11.75"

Registry build 21.09.26
8manufacturers in China registered for this device type
20catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Shandong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HCY
Manufacturer City Province Registered as Device types
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zhejiang Medicines & Health Products I/ E Co., Ltd. Hangzhou Zhejiang Exporter 41
Anhui Dajiang Medical Products Co., Ltd. Chuzhou Anhui Manufacturer 12
Zhangzhou Aoxi Plastic Co., Ltd. Zhangzhou Fujian Manufacturer 7

Record

Regulatory record for GEN2
Listed by Surgix Medical LLC, United States
FDA product code HCY
Device type Curette, Uterine
Device class Class 1
Regulation 21 CFR 884.4530
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-01-09
Record revised 2025-06-17 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Length 9.5 to 11.75 in
Distribution end date 2025-06-16

Catalogue Numbers

Catalogue numbers for GEN2
Catalogue number Size Status
G2OB1538 Length 11 in In distribution
G2OB1575 In distribution
G2OB1542 Length 11 in In distribution
G2OB1541 Length 11 in In distribution
G2OB1543 Length 11 in In distribution
G2G37060 Length 11 in In distribution
G2OB1599 Length 11 in In distribution
G2OB1600 Length 11 in In distribution
G2OB1624 Length 11.75 in In distribution
G2G37057 Length 9.5 in In distribution
G2OB1539 Length 11 in In distribution
G2OB1537 Length 11 in In distribution
G2G37059 In distribution
G2OB1536 Length 11 in In distribution
G2OB1540 Length 11 in In distribution
G2G36046 In distribution
G2OB1574 In distribution
G2G37058 In distribution
G2G36932 Length 11.75 in In distribution
G2G37060 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 1,021
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 118
Aesculap Aesculap AG 105
Sklar® Sklar Corporation 85
Millennium Avalign Technologies, Inc. 78
Hayden Medical Hayden Medical Inc 68
Novo Surgical Inc. Novo Surgical, Inc. 67
Novo Surgical Novo Surgical, Inc. 50
Ambler Surgical Ambler Surgical, LLC 37
Integra® Miltex® Integra LifeSciences Production Corporation 36
V. Mueller Steris Corporation 34
MedGyn Uterine Curette Medgyn Products, Inc. 33

Showing 12 of 59. All products under Curette, Uterine

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