SurgiMend PRS Meshed, Revize-X
K-Number: K171357 · 2017-06-07
Decision Date2017-06-07
Product CodeOXH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SurgiMend PRS Meshed, Revize-X is a medical device manufactured by Integra Lifesciences Corporation (Owner of Tei Biosciences). It received FDA 510(k) clearance on 2017-06-07 under approval number K171357. The device is classified under product code OXH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SurgiMend PRS Meshed, Revize-X?
SurgiMend PRS Meshed, Revize-X is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Integra Lifesciences Corporation (Owner of Tei Biosciences). The 510(k) number is K171357.
When was SurgiMend PRS Meshed, Revize-X approved by the FDA?
SurgiMend PRS Meshed, Revize-X received FDA 510(k) clearance on 2017-06-07, under approval number K171357.
What company makes SurgiMend PRS Meshed, Revize-X?
SurgiMend PRS Meshed, Revize-X is manufactured by Integra Lifesciences Corporation (Owner of Tei Biosciences).
What is the FDA product code for SurgiMend PRS Meshed, Revize-X?
The FDA product code for SurgiMend PRS Meshed, Revize-X is OXH.
Related Devices (Code: OXH)
Official Source
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