Biodesign Staple Line Reinforcement
K-Number: K170945 · 2017-04-28
ApplicantCook Biotech Incorporated
Decision Date2017-04-28
Product CodeOXE
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Biodesign Staple Line Reinforcement is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2017-04-28 under approval number K170945. The device is classified under product code OXE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biodesign Staple Line Reinforcement?
Biodesign Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K170945.
When was Biodesign Staple Line Reinforcement approved by the FDA?
Biodesign Staple Line Reinforcement received FDA 510(k) clearance on 2017-04-28, under approval number K170945.
What company makes Biodesign Staple Line Reinforcement?
Biodesign Staple Line Reinforcement is manufactured by Cook Biotech Incorporated.
What is the FDA product code for Biodesign Staple Line Reinforcement?
The FDA product code for Biodesign Staple Line Reinforcement is OXE.
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Related Devices (Code: OXE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.