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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 a medical device manufactured by Synovis Life Technologies, Inc.. It received FDA 510(k) clearance on 2023-04-07 under approval 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. It is manufactured by Synovis Life Technologies, Inc.. The 510(k) number is K223052.

When was Peri-Guard and Supple Peri-Guard approved by the FDA?

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

What company makes Peri-Guard and Supple Peri-Guard?

Peri-Guard and Supple Peri-Guard is manufactured by Synovis Life Technologies, Inc..

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 Devices by Synovis Life Technologies, Inc.

K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch K221032Vascu-Guard Vascular Repair Patch

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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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