OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT— 510(k) K935434

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K935434 for OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT, Substantially Equivalent on 1994-05-27. Applicant: United States Surgical, A Division of Tyco Healthc.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 1993-11-10
Decision date: 1994-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

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Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.