Skip to content

Looking Glass 4K Integrated Visualization System

by Conmed Corporation

510(k) K201593

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201593↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK201593 Date8 Jul 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 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 Looking Glass 4K Integrated Visualization System is a high-resolution surgical imaging device designed for laparoscopic and arthroscopic procedures. It employs 4K 3-chip CMOS camera technology to deliver precise, detailed visualisation for multi-specialty use in gastroenterology and urology applications.

This system integrates a 32-inch LED monitor with a Camera Connector Interface (CCI), optimising space efficiency in the operating room. Supplied as a reusable device, it adheres to FDA 510(k) clearance under Special Review (K201593) and EU MDR compliance. Storage and handling follow standard surgical imaging protocols to maintain performance and sterility.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Questions

AI-generated answers, 18 Sep 2026

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

  • What types of surgical procedures is the Looking Glass 4K Integrated Visualization System primarily used for?

    The Looking Glass 4K Integrated Visualization System is designed for laparoscopic and arthroscopic procedures, with a focus on applications in gastroenterology and urology. Its high-resolution 4K imaging provides detailed visualization, making it suitable for precision tasks in these specialties.

  • Is the Looking Glass 4K system reusable, or is it intended for single-use?

    The Looking Glass 4K Integrated Visualization System is reusable, as explicitly stated in the manufacturer’s description. It follows standard surgical imaging protocols for storage and handling to maintain performance and sterility.

  • How does the system optimize space efficiency in the operating room?

    The system integrates a 32-inch LED monitor with a Camera Connector Interface (CCI), which is designed to streamline setup and reduce clutter in the operating room, improving workflow and space utilization.

  • What regulatory pathways does the Looking Glass 4K system follow?

    The device is cleared under FDA 510(k) Special Review (K201593) and complies with EU MDR (Medical Device Regulation). It is classified under Product Code GCJ and was reviewed by the Gastroenterology and Urology (GU) advisory committee for its intended applications.