Gastroduodenal Ftrd Set

The gastroduodenal FTRD Set is a novel tool for diagnostic and therapeutic full-thickness (or deep wall resection, especially in the stomach) resection via flexible endoscopy in the stomach…

Registry build 21.09.26

The gastroduodenal FTRD Set is a novel tool for diagnostic and therapeutic full-thickness (or deep wall resection, especially in the stomach) resection via flexible endoscopy in the stomach and duodenum • technology is based on the well-established OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • the transection of the tissue happens only after the tissue has been closed completely • bowel lumen and abdominal cavity won’t get into contact • It consists of the following five instruments, all single-use: • gastroduodenal FTRD (application cap with preloaded clip (special design for use in duodenum), integrated HF snare, endoscope sleeve, hand wheel and thread retriever • for colonoscopes) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD) • Insertion balloon (used to facilitate the insertion of the gastroduodenal FTRD through the mouth in the upper GI tract | consists of a balloon, radiopaque markers, a catheter, a three-way handle and a yellow marker) • Guide wire (provided as insertion aid for the gastroduodenal FTRD to facilitate the insertion of the device into the upper GI-tract | used in conjunction with an insertion balloon)

17manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (9), Jiangsu (4), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PKL
Manufacturer City Province Registered as Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Zhejiang Huanyi Sterilization Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 25
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Jiana Sterilization Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 23
Promisemed Hangzhou Meditech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 21
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Changzhou Jiangsu Manufacturer 20
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19
Ningbo Huakun Medical Equipment Co., Ltd. Cixi Zhejiang Contract manufacturer 19
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13

Showing 12 of 17. All 17 manufacturers in China registered for Hemostatic Metal Clip For The Gi Tract

Record

Regulatory record for gastroduodenal Ftrd Set
Listed by Ovesco Endoscopy AG, Germany
FDA product code PKL
Device type Hemostatic Metal Clip For The Gi Tract
Device class Class 2
Regulation 21 CFR 876.4400
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K200684
Record published 2020-06-05

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 10 to 35 °C; Storage environment humidity 15 to 70 % RH
Sizes Balloon length 1800 mm; balloon diameter 20 mm; guidewire length 3700 mm; guidewire diameter 0.035 in

Catalogue Numbers

Catalogue numbers for gastroduodenal Ftrd Set
Catalogue number Size Status
FTRD 13 Balloon Length 1800 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hemostatic Metal Clip For The Gi Tract Hangzhou AGS MedTech Co., Ltd. 368
Disposable Hemostatic Clips Ningbo Xinwell Medical Technology Co., Ltd. 160
Single Use Hemoclip Zhejiang Chuangxiang Medical Technology Co., Ltd. 80
SureClip Micro-Tech (Nanjing) Co., Ltd. 38
Lockado(TM) Repositionable Hemostasis Clip Micro-Tech (Nanjing) Co., Ltd. 32
Zksk Beijing Zksk Technology Co., Ltd. 30
RiteClip(TM) Repositionable Hemostasis Clip Micro-Tech (Nanjing) Co., Ltd. 30
S.t.a.r(TM) Disposable Hemostatic Closure Clip Device Micro-Tech (Nanjing) Co., Ltd. 24
Dual Action Tissue Closure Device Micro-Tech (Nanjing) Co., Ltd. 18
Otsc System Set Ovesco Endoscopy AG 17
Otsc System Set Ovesco Endoscopy USA 17
Single Use Multiclip Device Micro-Tech (Nanjing) Co., Ltd. 12

Showing 12 of 52. All products under Hemostatic Metal Clip For The Gi Tract

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K251562 2025-12-18
K241858 2024-08-26
K200684 2020-06-02
K183309 2019-10-22
K170867 2017-07-25
K153550 2016-10-12
K150067 2015-09-16
K101428 2010-12-01

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