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Endoboy

by Geyser S.A.

510(k) K033644

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 NumberK033644 Date24 Mar 2004ClearedStatusActive

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  • Withdrawn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, 26 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 Endoboy is a medical device classified under product code GCJ. It is intended for use within the fields of gastroenterology and urology.

This device is subject to FDA 510k authorization and was determined to be substantially equivalent through a traditional clearance process. It is identified by the K-number K033644.

Questions

AI-generated answers, 26 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 intended clinical use of the Endoboy?

    The Endoboy is designed for use within the medical fields of gastroenterology and urology. It is classified under product code GCJ, which relates to these specific clinical specialties.

  • What is the regulatory status of the Endoboy?

    The Endoboy has received FDA 510k authorization under the K-number K033644. It was determined to be substantially equivalent to predicate devices through a traditional clearance process completed on March 24, 2004.

  • Who is the manufacturer of the Endoboy device?

    The Endoboy is manufactured by Geyser S.A., located in Coudes, France. The company submitted the device for review under the traditional 510k pathway.