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Uterine Manipulator/Injector

by Catheter Research, Inc.

510(k) K974357

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974357 Date2 Feb 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LKF
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Uterine Manipulator/Injector is a Class 2 medical device used during gynecological procedures including diagnostic laparoscopy, minilaparotomy, fertility exams, and salpingoplasty. It facilitates manipulation of the uterus and injection of fluids or dyes for visualization or diagnostic purposes.

The device is manufactured by Catheter Research, Inc. and is intended for use by physicians in clinical or surgical settings. It is supplied as a single-use device and is not MRI compatible. The device has FDA 510(k) clearance with product code LKF and is regulated under 884.4530.

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