AUTO SUTURE* ANTI-FOG DEVICE**— 510(k) K944249

Name: FDA 510(k) clearance K944249
Creator: U.S. Food and Drug Administration
Published: 1994-09-20

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K944249 for AUTO SUTURE* ANTI-FOG DEVICE**, Substantially Equivalent on 1994-09-20. 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 FEB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-08-30
Decision date: 1994-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.