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FUJINON Video Laparoscope-Additional Intended Use

by Fujinon, Inc. 510(k)

Active United States

510(k) K925599

Overview

The FUJINON Video Laparoscope-Additional Intended Use is a medical device designed for laparoscopic procedures. It is a video laparoscope that provides visualization during minimally invasive surgical procedures in the gastrointestinal and urological fields.

This device is manufactured by Fujinon, Inc. and is supplied as a reusable instrument. It received FDA 510(k) clearance on July 28, 1993, with K number K925599, and is classified under product code GCJ. The device is intended for use in gastroenterology and urology procedures as determined by the review advisory committee.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925599 Date28 Jul 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the FUJINON Video Laparoscope-Additional Intended Use used for?

    The FUJINON Video Laparoscope-Additional Intended Use is designed for laparoscopic procedures in the gastrointestinal and urological fields, providing visualization during minimally invasive surgical procedures.

  • Is the FUJINON Video Laparoscope reusable or single-use?

    The FUJINON Video Laparoscope is supplied as a reusable instrument, meaning it can be used multiple times after appropriate cleaning and sterilization according to manufacturer guidelines.

  • What regulatory approvals does the FUJINON Video Laparoscope have?

    The device received FDA 510(k) clearance on July 28, 1993, with K number K925599, and is classified under product code GCJ. It was determined to be substantially equivalent to predicate devices.

  • What procedures is this laparoscope specifically intended for?

    The FUJINON Video Laparoscope-Additional Intended Use is specifically intended for use in gastroenterology and urology procedures as determined by the review advisory committee during the FDA clearance process.