PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology— 510(k) K213125

Substantially Equivalent

Synovis Life Technologies. Inc. (A Subsidiary of Baxter

FDA 510(k) clearance K213125 for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology, Substantially Equivalent on 2021-10-27. Applicant: Synovis Life Technologies. Inc. (A Subsidiary of Baxter.

Clearance details

Applicant
Synovis Life Technologies. Inc. (A Subsidiary of Baxter
Product code
Code FTM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

Source: openFDA MAUDE database, through . 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.