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HMT Endoscreen, Model ESC 501

by Servicetrends, Inc.

510(k) K942155

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 NumberK942155 Date1 Jul 1994ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 19 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 HMT Endoscreen, Model ESC 501 is a light source, fiberoptic device for routine use in gastroenterology and urology procedures. It provides illumination for endoscopic examinations in these medical specialties.

This device is manufactured by Servicetrends, Inc. and is FDA 510(k) cleared with K number K942155, classified as a class II medical device. It is supplied in various sizes as indicated by the multiple registration numbers associated with this product code.

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Questions

AI-generated answers, 19 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 HMT Endoscreen, Model ESC 501 used for?

    The HMT Endoscreen, Model ESC 501 is a light source and fiberoptic device designed for routine use in gastroenterology and urology procedures to provide illumination during endoscopic examinations.

  • Is the HMT Endoscreen reusable or single-use?

    The device data does not specify whether the HMT Endoscreen is reusable or single-use, so this information is not available from the provided documentation.

  • What sizes or models of the HMT Endoscreen are available?

    The device is supplied in various sizes as indicated by the multiple registration numbers associated with this product code, though specific size details are not provided in the documentation.

  • How should the HMT Endoscreen be stored?

    The device data does not include specific storage instructions for the HMT Endoscreen, Model ESC 501.

  • What is the regulatory status of the HMT Endoscreen?

    The HMT Endoscreen, Model ESC 501 is FDA 510(k) cleared with K number K942155, classified as a class II medical device, and is substantially equivalent to other devices on the market.