← Back to catalogue

gastroduodenal FTRD Set

FDA UDI

Class II (US FDA UDI)

by Ovesco Endoscopy AG

Identity

Trade Name
gastroduodenal FTRD Set FDA UDI
Generic Name
Endoscopic electrosurgical full-thickness tissue biopsy/resection set FDA UDI
Device Name
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) FDA UDI
Model / Reference
FTRD 13 FDA UDI
Description
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) FDA UDI

Identifiers

Catalog Number
200.72 FDA UDI
Primary DI / UDI-DI
04260206310655 FDA UDI
510(k) Number
K200684 FDA UDI
FDA Product Code
PKL FDA UDI
FDI FDA UDI
KNS FDA UDI
GMDN Term
Endoscopic electrosurgical full-thickness tissue biopsy/resection set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4400 FDA UDI
876.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Balloon Length — 1800 Millimeter FDA UDI
Balloon Diameter — 20 Millimeter FDA UDI
Guidewire Length — 3700 Millimeter FDA UDI
Guidewire Diameter — 0.035 Inch FDA UDI

Category: Endoscopic electrosurgical full-thickness tissue biopsy/resection set

gastroduodenal FTRD Set by Ovesco Endoscopy AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical full-thickness tissue biopsy/resection set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ovesco Endoscopy AG

Sources (1)

  • FDA UDI 6d4fbbbd-6850-47b7-910f-77ef01d635de 38 fields · synced May 30, 2026