AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*— 510(k) K896434

Name: FDA 510(k) clearance K896434
Creator: U.S. Food and Drug Administration
Published: 1989-11-16

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K896434 for AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*, Substantially Equivalent on 1989-11-16. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 1.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GEA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1989-11-09
Decision date: 1989-11-16
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 GEA

product code GEA

Malfunction: 587
Total: 587

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.