UTERINE MANIPULATOR/INJECTOR WITH SPRING— 510(k) K941458

Name: FDA 510(k) clearance K941458
Creator: U.S. Food and Drug Administration
Published: 1995-01-25

Substantially Equivalent

Zinnanti Surgical Instruments, Inc.

FDA 510(k) clearance K941458 for UTERINE MANIPULATOR/INJECTOR WITH SPRING, Substantially Equivalent on 1995-01-25. Applicant: Zinnanti Surgical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Zinnanti Surgical Instruments, Inc.
Product code: Code LKF
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1994-03-25
Decision date: 1995-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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K925501 — NYLON COATED SPECULA1997-06-13
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K925560 — ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES1994-08-30
K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE1994-06-07
K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE1994-06-07

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.