BARS Set 100.60

GUDID 04260206310983

The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is based on the OTSC System • the two BARS Anchors are used for mobilizing tissue into the application cap • the SpaceKeeper Balloon can secure that a rest lumen maintains open • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Ovesco Endoscopy AG

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
Primary Device ID04260206310983
NIH Device Record Keyf52eb525-2137-4926-9e9c-0c3afc86d2b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBARS Set
Version Model NumberBARS Set
Catalog Number100.60
Company DUNS344007369
Company NameOvesco Endoscopy AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com
Phone+49707196528160
Emailservice@ovesco.com

Device Dimensions

Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Balloon Length1800 Millimeter
Balloon Diameter20 Millimeter
Balloon Length1850 Millimeter
Balloon Diameter6 Millimeter
Guidewire Length3700 Millimeter
Guidewire Diameter0.035 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104260206310983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKLHemostatic Metal Clip For The Gi Tract

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-09
Device Publish Date2024-11-29

Devices Manufactured by Ovesco Endoscopy AG

04260206311911 - AWCduo2025-06-13 The AWCduo is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushin
04260206311935 - AWCduo2025-06-13 The AWCduo is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushin
04260206310983 - BARS Set2024-12-09The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is based on the OTSC System • the two BARS Anchors are used for mobilizing tissue into the application cap • the SpaceKeeper Balloon can secure that a rest lumen maintains open • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant
04260206310983 - BARS Set2024-12-09 The BARS Set is a novel tool for the closure or partial closure of lumina and wall defects in the stomach. • technology is bas
04260206311263 - BARS Anchor silver2022-11-30 The application aid BARS Anchor is an anchor-shaped instrument for the fixation of tissue when using flexible endoscopes in conj
04260206311270 - BARS Anchor black2022-11-30 The application aid BARS Anchor is an anchor-shaped instrument for the fixation of tissue when using flexible endoscopes in conj
04260206311379 - BougieCap2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c
04260206311393 - BougieCap2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c
04260206311416 - BougieCap2022-10-10 The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual c
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.