OviTex PRS (Long-Term Resorbable)
K-Number: K243595 · 2024-12-19
ApplicantTELA Bio, Inc.
Decision Date2024-12-19
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
OviTex PRS (Long-Term Resorbable) is a medical device manufactured by TELA Bio, Inc.. It received FDA 510(k) clearance on 2024-12-19 under approval number K243595. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OviTex PRS (Long-Term Resorbable)?
OviTex PRS (Long-Term Resorbable) is a medical device that received FDA 510(k) clearance on 2024-12-19. It is manufactured by TELA Bio, Inc.. The 510(k) number is K243595.
When was OviTex PRS (Long-Term Resorbable) approved by the FDA?
OviTex PRS (Long-Term Resorbable) received FDA 510(k) clearance on 2024-12-19, under approval number K243595.
What company makes OviTex PRS (Long-Term Resorbable)?
OviTex PRS (Long-Term Resorbable) is manufactured by TELA Bio, Inc..
What is the FDA product code for OviTex PRS (Long-Term Resorbable)?
The FDA product code for OviTex PRS (Long-Term Resorbable) is FTM.
Other Devices by TELA Bio, Inc.
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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.