AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR— 510(k) K930867

Name: FDA 510(k) clearance K930867
Creator: U.S. Food and Drug Administration
Published: 1994-07-25

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K930867 for AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR, Substantially Equivalent on 1994-07-25. 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 LKF
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1993-02-19
Decision date: 1994-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER2006-11-02
K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2006-10-23
K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE2006-09-01

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.