AUTO SUTURE ABBI SYSTEM— 510(k) K983296

Name: FDA 510(k) clearance K983296
Creator: U.S. Food and Drug Administration
Published: 1999-06-04

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K983296 for AUTO SUTURE ABBI SYSTEM, Substantially Equivalent on 1999-06-04. 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 KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1998-09-21
Decision date: 1999-06-04
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 KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.