FDA 510(k)

Lyograft

K-Number: K192452 · 2020-09-03

Decision Date2020-09-03

Product CodeFTM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Lyograft is the device name listed in this FDA 510(k) record. The listed applicant is B. Bruan Surgical, SA. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K192452. 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 Lyograft?

Lyograft is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is B. Bruan Surgical, SA. The 510(k) number is K192452.

When did Lyograft receive FDA 510(k) clearance?

Lyograft received FDA 510(k) clearance on 2020-09-03, under 510(k) number K192452.

Who is the listed applicant for Lyograft?

The FDA 510(k) record lists B. Bruan Surgical, SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lyograft?

The FDA product code for Lyograft is FTM.

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 Scientific K250598Endoform 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

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