AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE— 510(k) K905426

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K905426 for AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE, Substantially Equivalent on 1991-02-11. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1990-12-04
Decision date: 1991-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.