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)
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
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
FDI
Product Code Name
Snare, Flexible
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |