Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OviTex PRS (Long Term Resorbable)

K-Number: K214070 · 2023-03-21

ApplicantTela Bio
Decision Date2023-03-21
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OviTex PRS (Long Term Resorbable) is the device name listed in this FDA 510(k) record. The listed applicant is Tela Bio. It received FDA 510(k) clearance on 2023-03-21 under 510(k) 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. The listed applicant is Tela Bio. The 510(k) number is K214070.

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

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

Who is the listed applicant for OviTex PRS (Long Term Resorbable)?

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

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

The FDA product code for OviTex PRS (Long Term Resorbable) 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_RECRUITINGNCT07070115Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®RECRUITINGNCT07135596Effectiveness and Safety of OviTex® PRS in Breast ReconstructionRECRUITING

Other records listing Tela Bio 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)K241126OviTex PRS

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.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

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.

↑