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FDA 510(k)

OviTex PRS

K-Number: K241126 · 2024-05-22

ApplicantTELA Bio, Inc.
Decision Date2024-05-22
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OviTex PRS is a medical device manufactured by TELA Bio, Inc.. It received FDA 510(k) clearance on 2024-05-22 under approval number K241126. 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?

OviTex PRS is a medical device that received FDA 510(k) clearance on 2024-05-22. It is manufactured by TELA Bio, Inc.. The 510(k) number is K241126.

When was OviTex PRS approved by the FDA?

OviTex PRS received FDA 510(k) clearance on 2024-05-22, under approval number K241126.

What company makes OviTex PRS?

OviTex PRS is manufactured by TELA Bio, Inc..

What is the FDA product code for OviTex PRS?

The FDA product code for OviTex PRS is FTM.

Other Devices by TELA Bio, Inc.

K243595OviTex PRS (Long-Term Resorbable)

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K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) K162554Gentrix Surgical MatrixAcell, Inc. K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)

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.

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