AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP— 510(k) K904588

Name: FDA 510(k) clearance K904588
Creator: U.S. Food and Drug Administration
Published: 1990-12-24

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K904588 for AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP, Substantially Equivalent on 1990-12-24. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GAL
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 1990-09-26
Decision date: 1990-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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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.