Peri-Guard and Supple Peri-Guard— 510(k) K223052

Substantially Equivalent

Synovis Life Technologies, Inc.

FDA 510(k) clearance K223052 for Peri-Guard and Supple Peri-Guard, Substantially Equivalent on 2023-04-07. Applicant: Synovis Life Technologies, Inc..

Clearance details

Applicant: Synovis Life Technologies, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2022-09-29
Decision date: 2023-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.