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FDA 510(k)

Peri-Guard and Supple Peri-Guard

K-Number: K223052 · 2023-04-07

ApplicantSynovis Life Technologies, Inc.
Decision Date2023-04-07
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Peri-Guard and Supple Peri-Guard is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies, Inc.. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223052. 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 Peri-Guard and Supple Peri-Guard?

Peri-Guard and Supple Peri-Guard is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Synovis Life Technologies, Inc.. The 510(k) number is K223052.

When did Peri-Guard and Supple Peri-Guard receive FDA 510(k) clearance?

Peri-Guard and Supple Peri-Guard received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223052.

Who is the listed applicant for Peri-Guard and Supple Peri-Guard?

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

What is the FDA product code for Peri-Guard and Supple Peri-Guard?

The FDA product code for Peri-Guard and Supple Peri-Guard is FTM.

Other records listing Synovis Life Technologies, 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.

K221032Vascu-Guard Vascular Repair PatchK221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

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.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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