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Mahe Instruments

by Mahe-Medizintechnik 2 variants

510(k) K935442

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 NumberK935442 Date14 Mar 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  • Withdrawn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
GCJ
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.

Mahe Instruments are medical devices manufactured by Mahe-Medizintechnik. These instruments are designed for use in gastroenterology and urology procedures. The device has been classified under product code GCJ and received FDA 510(k) clearance.

The instruments are supplied by Mahe-Medizintechnik located in Nashville, Tennessee. They are regulated medical devices with FDA clearance number K935442. No information regarding sterility, single-use status, MRI safety, or specific sizes is provided in the device data.

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