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Lumax (Modification)

by Medamicus, Inc.

510(k) K953734

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 NumberK953734 Date18 Jan 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  • Withdrawn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
FEN
Device Class
Class II
Regulation
21 CFR Part 876.1620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Lumax (Modification) is a Device, Cystometric, Hydraulic, which is substantially equivalent to other devices. It is classified as a class 2 device.

The device is supplied with a registration number and is used in the medical specialties of Gastroenterology and Urology. It has an FDA 510K authorization and is subject to regulation number 876.1620. The device is associated with product code FEN.

Other devices from Medamicus, Inc.

See all devices from Medamicus, Inc. →

Questions

AI-generated answers, 23 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 Lumax device used for?

    The Lumax device is used in the medical specialties of Gastroenterology and Urology, specifically for cystometric procedures.

  • Is the Lumax device sterile?

    The device data does not specify the sterility of the Lumax device, but it is subject to regulation number 876.1620.

  • What is the regulatory status of the Lumax device?

    The Lumax device has an FDA 510K authorization, indicating it is substantially equivalent to other devices.

  • What product code is associated with the Lumax device?

    The Lumax device is associated with product code FEN.