FDA 510(k)

OviTex PRS (Long Term Resorbable)

K-Number: K214070 · 2023-03-21

Decision Date2023-03-21

Product CodeFTM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OviTex PRS (Long Term Resorbable) is a medical device manufactured by Tela Bio. It received FDA 510(k) clearance on 2023-03-21 under approval number K214070. 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 2023-03-21. It is manufactured by Tela Bio. The 510(k) number is K214070.

When was OviTex PRS (Long Term Resorbable) approved by the FDA?

OviTex PRS (Long Term Resorbable) received FDA 510(k) clearance on 2023-03-21, under approval number K214070.

What company makes OviTex PRS (Long Term Resorbable)?

OviTex PRS (Long Term Resorbable) is manufactured by Tela Bio.

What is the FDA product code for OviTex PRS (Long Term Resorbable)?

The FDA product code for OviTex PRS (Long Term Resorbable) is FTM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.