K930416

Substantially Equivalent for Some Indications

SURGICAL SUTURE PACKAGE INSERTS

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: GAL
Advisory panel: General, Plastic Surgery
Date received: 1993-01-26
Decision date: 1994-04-28
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Norwalk, CT, US

Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.