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C-Mount Objective Lens F = 17 Mm, Steam-Sterilizable: Model 85 261.172, C-Mount Objective Lens F = 21 Mm, Steam-Steriliz

by Richard Wolf Medical Instruments Corp.

510(k) K964173

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 NumberK964173 Date13 Dec 1996ClearedStatusActive

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  • Withdrawn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
FET
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

This device is an endoscopic video imaging system component, specifically a C-mount objective lens designed for use with endoscopes. It serves to connect the endoscope to video cameras and enables video-controlled diagnostics and therapy through a clamping mechanism that allows quick adaptation and fixation of standard telescopes with eyepiece.

The lens is steam-sterilizable and supplied as a reusable component. It is authorized under FDA 510(k) clearance K964173, classified as a Class II device under regulation 876.1500, and was determined to be substantially equivalent to a predicate device. The device is intended for use in gastroenterology and urology settings.

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Questions

AI-generated answers, 25 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 is the C-mount objective lens used for?

    The C-mount objective lens connects endoscopes to video cameras, enabling video-controlled diagnostics and therapy by allowing quick adaptation and fixation of standard telescopes with eyepiece through a clamping mechanism.

  • Is the lens reusable or single-use, and how is it sterilized?

    The lens is supplied as a reusable component and is steam-sterilizable, meaning it can be cleaned and sterilized using steam autoclaving for multiple uses in clinical settings.

  • What are the focal lengths and model number of this lens?

    This device includes two focal lengths: 17mm and 21mm, and is identified by the model number 85 261.172, which distinguishes it from other similar lenses in the manufacturer's product line.