Aesculap

Cottle Fishtail Chislw/Protct END178MM

Registry build 21.09.26
10manufacturers in China registered for this device type
42catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (3), Zhejiang (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FZO
Manufacturer City Province Registered as Device types
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24

Record

Regulatory record for Aesculap
Listed by Aesculap AG, Germany
FDA product code FZO
Device type Chisel, Surgical, Manual
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-07-29
Record revised 2025-11-13 (version 4)

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
Distribution end date 2025-01-22
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aesculap
Catalogue number Size Status
FF610R In distribution
FL184R In distribution
OL304R In distribution
FL174R In distribution
FL685R In distribution
OL305R In distribution
FL186R In distribution
OL302R In distribution
FL670R In distribution
FL668R In distribution
OL311R In distribution
FL176R In distribution
FL506R In distribution
OL319R In distribution
FL687R In distribution
FL126R In distribution
OL314R In distribution
FL666R In distribution
OL320R In distribution
FL124R In distribution
FL504R In distribution
OL303R In distribution
FL173R In distribution
FL507R In distribution
FB918R In distribution
ND105R In distribution
OL307R In distribution
FL672R In distribution
FL183R In distribution
FL187R In distribution
FL665R In distribution
FL175R In distribution
OL301R In distribution
FL120R In distribution
FL505R In distribution
FL185R In distribution
FL503R In distribution
FL128R In distribution
FL122R In distribution
FL430R In distribution
FD907R Withdrawn
ND076R Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surtex Surtex Instruments Ltd 297
Sklar Sklar Corporation 175
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 119
Timberline Lateral Fusion System Highridge Medical, LLC 96
Ambler Surgical Ambler Surgical, LLC 95
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 87
Integra® Jarit® Integra LifeSciences Production Corporation 60
Boss Instruments Boss Instruments, Ltd. 52
Integra® Miltex® Integra LifeSciences Production Corporation 50
Kmedic Teleflex Medical LLC 41
American Medicals American Medicals 41
Chisel, Surgical, Manual Synthes Gmbh 41

Showing 12 of 179. All products under Chisel, Surgical, Manual

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