gastroduodenal FTRD Set - The gastroduodenal FTRD Set is a novel tool for - Ovesco Endoscopy AG

Duns Number:344007369

Device Description: The gastroduodenal FTRD Set is a novel tool for diagnostic and therapeutic full-thickness 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)

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More Product Details

Catalog Number

200.72

Brand Name

gastroduodenal FTRD Set

Version/Model Number

FTRD 13

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200684

Product Code Details

Product Code

FDI

Product Code Name

Snare, Flexible

Device Record Status

Public Device Record Key

6d4fbbbd-6850-47b7-910f-77ef01d635de

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OVESCO ENDOSCOPY AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 61