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Video Sigmoidoscope

by Welch Allyn, Inc.

510(k) K950429

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 NumberK950429 Date1 Aug 1995ClearedStatusActive

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  • Withdrawn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
FAM
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

A video sigmoidoscope is a flexible or rigid endoscopic device used to visualize the sigmoid colon and rectum. It provides illumination and visualization for diagnostic examination of the rectal and anal cavity.

The device is used in clinical settings for endoscopic procedures and may be supplied as reusable or single-use depending on the model. It is authorized under FDA 510(k) clearance K950429 and classified as a Class II medical device under regulation number 876.1500.

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Questions

AI-generated answers, 27 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 video sigmoidoscope used for?

    The video sigmoidoscope is used to visualize the sigmoid colon and rectum, providing illumination and visualization for diagnostic examination of the rectal and anal cavity in clinical endoscopic procedures.

  • Is the video sigmoidoscope reusable or single-use?

    The device may be supplied as reusable or single-use depending on the specific model, as indicated in the device description, allowing flexibility based on clinical needs and infection control protocols.

  • What regulatory authorization does the video sigmoidoscope have?

    The video sigmoidoscope is authorized under FDA 510(k) clearance K950429, which determined it to be substantially equivalent to a legally marketed predicate device, and is classified as a Class II medical device under regulation number 876.1500.