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Murdoch Intraoperative Laparoscopic Lens Cleaner

by Cook Urological, Inc. 510(k)

Active United States

510(k) K935754

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK935754 Date2 May 1994ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Murdoch Intraoperative Laparoscopic Lens Cleaner is a surgical accessory designed to clean laparoscopic lenses during intraoperative procedures. It is used in gastroenterology and urology specialties to maintain optical clarity of the laparoscope lens while it is inside the patient. The device facilitates the removal of debris, fluids, and tissue from the lens surface without requiring removal of the scope from the surgical field.

The device is supplied by Cook Urological, Inc. and is intended for single use during surgical procedures. It is regulated under FDA product code GCJ and received 510(k) clearance under number K935754 with a substantially equivalent decision. The device is classified as a Class II medical device and is stored at room temperature prior to use. No MRI safety information is provided in the available specifications.

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