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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 the device name listed in this FDA 510(k) record. The listed applicant is TELA Bio, Inc.. It received FDA 510(k) clearance on 2024-05-22 under 510(k) 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. The listed applicant is TELA Bio, Inc.. The 510(k) number is K241126.

When did OviTex PRS receive FDA 510(k) clearance?

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

Who is the listed applicant for OviTex PRS?

The FDA 510(k) record lists TELA Bio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OviTex PRS?

The FDA product code for OviTex PRS is FTM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05736848A Retrospective Assessment of OviTex PRS (OviTex)ACTIVE_NOT_RECRUITINGNCT07135596Effectiveness and Safety of OviTex® PRS in Breast ReconstructionRECRUITINGNCT07070115Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®RECRUITING

Other records listing TELA Bio, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243595OviTex PRS (Long-Term Resorbable)K214070OviTex PRS (Long Term Resorbable)

Related Devices (Code: FTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.K214070OviTex PRS (Long Term Resorbable)Tela Bio

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.

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