TroClear

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear…

Registry build 21.09.26

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.

7manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (3), Anhui (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NWV
Manufacturer City Province Registered as Device types
Tonglu Qianyan Medtech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Anhui Shiyin Photoelectric Instrument Co., Ltd. Suzhou Anhui Specification developer 18
Tonglu Youshi Medical Instrument Co., Ltd. Tonglu Zhejiang Manufacturer 10
Anqing Changfan Medical Instrument Co., Ltd. Anqing Anhui Manufacturer 9
Suzhou SMH Co., Ltd. Suzhou Jiangsu Manufacturer 4
Hunan Handlike Minimally Invasive Surgery Co., Ltd. Changsha Hunan Manufacturer 3

Record

Regulatory record for TroClear
Listed by Mednium Corporation, United States
FDA product code NWV
Device type Laparoscopic Accessories, Gynecologic
Device class Class 1
Regulation 21 CFR 884.1720
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2024-09-12
Record revised 2024-10-16 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 10, carton of 100

Catalogue Numbers

Catalogue numbers for TroClear
Catalogue number Size Status
TC11 In distribution
TC7 In distribution
TC9 In distribution
TC5 In distribution
TC8 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 201
AED National Advanced Endoscopy Devices, Inc. 173
Elmed Elmed, Inc. 36
Elite National Advanced Endoscopy Devices, Inc. 8
Elmed Incorporated Elmed, Inc. 7
AbGrab Lapovations, LLC 6
Integra® Jarit® Integra LifeSciences Production Corporation 5
Laparoscopic Accessories, Gynecologic Stryker Sustainability Solutions 5
Speedlock National Advanced Endoscopy Devices, Inc. 5
Integra® Miltex® Integra LifeSciences Production Corporation 5
Eco Fit National Advanced Endoscopy Devices, Inc. 4
Laparoscopic Accessories, Gynecologic Richard Wolf Gmbh 3

Showing 12 of 80. All products under Laparoscopic Accessories, Gynecologic

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