SURGICAL SUTURE PACKAGE INSERTS— 510(k) K930416

Substantially Equivalent for Some Indications

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K930416 for SURGICAL SUTURE PACKAGE INSERTS, Substantially Equivalent for Some Indications on 1994-04-28. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant
United States Surgical, A Division of Tyco Healthc
Product code
Code GAL
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Norwalk, CT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GAL

product code GAL
Malfunction
681
Other
1
Total
682

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.