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Clearfield Anti-Fog Sterile Wipe, Product Number 300-004

by Tucson Medical Corp.

510(k) K974454

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 NumberK974454 Date18 Dec 1997ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 21 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 Clearfield Anti-Fog Sterile Wipe is a sterile wipe designed to prevent fogging on medical devices. It is classified as an anti-fog solution and accessory for use in endoscopy procedures.

This sterile wipe is supplied as a single-use product and is regulated under FDA 510K clearance with product code OCT. It is intended for use in gastroenterology and urology settings and is manufactured by Tucson Medical Corp.

Questions

AI-generated answers, 21 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 Clearfield Anti-Fog Sterile Wipe used for?

    The Clearfield Anti-Fog Sterile Wipe is designed to prevent fogging on medical devices during endoscopy procedures. It is specifically intended for use in gastroenterology and urology settings to maintain clear visibility during medical procedures.

  • Is the Clearfield Anti-Fog Sterile Wipe single-use or reusable?

    The Clearfield Anti-Fog Sterile Wipe is supplied as a single-use product. It is designed for one-time application to ensure sterility and optimal performance, and should not be reused or resterilized for patient safety reasons.

  • What is the regulatory status of the Clearfield Anti-Fog Sterile Wipe?

    The Clearfield Anti-Fog Sterile Wipe is regulated under FDA 510K clearance with product code OCT. It has been determined to be substantially equivalent to predicate devices and is classified as a Class II medical device for anti-fog solutions and accessories in endoscopy.

  • How is the Clearfield Anti-Fog Sterile Wipe supplied?

    The Clearfield Anti-Fog Sterile Wipe is supplied as a sterile wipe in individual packaging. It is manufactured by Tucson Medical Corp. and is intended for single-use application to medical devices to prevent fogging during endoscopic procedures in gastroenterology and urology settings.