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Olympus GF-UM3/EU-M3

by Olympus Corp. 510(k)

Active United States

510(k) K882061

Overview

The Olympus GF-UM3/EU-M3 is a fiber optic endoscope, classified under product code GDB and regulation 876.1500. Designed for use in gastroenterology and urology, it is a flexible, light-transmitting instrument used to visualize internal body cavities and structures. Its fiber optic technology enables high-resolution imaging for diagnostic and therapeutic procedures.

This endoscope is supplied as a reusable medical device and is intended for use in controlled clinical settings. It is not sterile upon receipt and requires appropriate cleaning, disinfection, and sterilization procedures before each use. The device adheres to FDA 510(k) clearance (K882061) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) issued in 1988. Compliance with regulatory standards ensures its safe application in endoscopic examinations.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882061 Date15 Nov 1988ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GDB
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 Olympus GF-UM3/EU-M3 used for?

    The Olympus GF-UM3/EU-M3 is a fiber optic endoscope designed for visualizing internal body cavities and structures in gastroenterology and urology. Its flexible, light-transmitting technology enables high-resolution imaging, making it suitable for both diagnostic and therapeutic procedures in controlled clinical settings.

  • Is the Olympus GF-UM3/EU-M3 supplied sterile?

    No, the Olympus GF-UM3/EU-M3 is not sterile upon receipt. It is a reusable medical device and must undergo thorough cleaning, disinfection, and sterilization procedures before each use to ensure safety and compliance with clinical standards.

  • How is the Olympus GF-UM3/EU-M3 regulated?

    The Olympus GF-UM3/EU-M3 holds FDA 510(k) clearance (K882061) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) issued in 1988. It falls under product code GDB and regulation 876.1500, ensuring its compliance with regulatory standards for endoscopy.

  • What specialties is the Olympus GF-UM3/EU-M3 approved for?

    The Olympus GF-UM3/EU-M3 is approved for use in gastroenterology and urology procedures. Its design and fiber optic technology are specifically tailored for these medical specialties to facilitate high-resolution internal imaging.

  • Why does the Olympus GF-UM3/EU-M3 require reprocessing before use?

    Since the Olympus GF-UM3/EU-M3 is a reusable device, it must undergo reprocessing—including cleaning, disinfection, and sterilization—to remove bioburden, prevent cross-contamination, and ensure it remains safe for repeated clinical use. This process is critical for maintaining device integrity and patient safety.