Arthcut

ARTHCUT Arthroscopy Scissors, complete instrument, straight, working length: 6 1/8", (155 mm), diam. 3,40 mm, serrated (coarse), vertical cutting, (8 mm), blunt/blunt, with tubular shaft,…

Registry build 21.09.26

ARTHCUT Arthroscopy Scissors, complete instrument, straight, working length: 6 1/8″, (155 mm), diam. 3,40 mm, serrated (coarse), vertical cutting, (8 mm), blunt/blunt, with tubular shaft, ring handle, single action, consisting of FO725R, FO728R, FO761R, detachable, non-sterile, reusable

21manufacturers in China registered for this device type
6catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRX
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Sanmina Kunshan Jiangsu Contract manufacturer 15
Peter’s Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Jiangsu Shenli Medical Production Co., Ltd. Changzhou Jiangsu Contract manufacturer 6
PAN-International Precision Electronic Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26

Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope

Record

Regulatory record for Arthcut
Listed by Aesculap AG, Germany
FDA product code HRX
Device type Arthroscope
Device class Class 2
Regulation 21 CFR 888.1100
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-05-20
Record revised 2022-09-23 (version 3)

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Arthcut
Catalogue number Size Status
FO677R In distribution
FO687R In distribution
FO681R Working length (mm) : 155.000 MM In distribution
FO678R In distribution
FO673R In distribution
FO682R Diameter (mm) : 3.400 MM In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 299
Arthroscope Karl Storz GmbH & Co. KG 278
Conmed/Linvatec Provision 265
Arthroscope Smith & Nephew, Inc. 255
Medline Medline Industries, Inc. 205
Arthroscope Sterilmed, Inc. 184
Sustainable Technologies Provision 150
Medline Renewal Medline Industries, Inc. 123
Stryker Provision 113
Arthrex® Arthrex, Inc. 109
Arthrex Provision 109
Eberle Eberle GmbH & Co. KG 92

Showing 12 of 567. All products under Arthroscope

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K003740 2001-04-27
K954652 1996-02-14
K904859 1991-03-15

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