Surtex

Tonsil Needle Tapered Tip - With Luer Lock Connection Needle Diameter 0.65 mm ? Stainless Steel

Registry build 21.09.26
3manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (2), Shanghai (1).

Chinese manufacturers registered for FDA product code KTE
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19

Record

Regulatory record for Surtex
Listed by Surtex Instruments Ltd, United Kingdom
FDA product code KTE
Device type Trocar, Ent
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Remanufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2026-05-12

Specifications

Specifications
MRI safety MR Conditional

Catalogue Numbers

Catalogue numbers for Surtex
Catalogue number Size Status
TR-480-20 In distribution
TR-493-20 In distribution
TR-480-18 In distribution
TR-480-15 In distribution
TR-490-10 In distribution
TR-491-15 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 15
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 14
Aesculap Aesculap AG 10
Integra® Integra LifeSciences Production Corporation 7
V. Mueller Steris Corporation 6
TraumaOne System Biomet Microfixation 4
Boss Instruments Boss Instruments, Ltd. 4
MicroFrance® Integra Microfrance SAS 4
Antrum trocar, oblique beak Spiggle & Theis Medizintechnik Gmbh 3
Pilling Teleflex Medical LLC 3
Millennium Avalign Technologies, Inc. 3
BI-Phase System Biomet Microfixation 2

Showing 12 of 28. All products under Trocar, Ent

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