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Evis Eus Ultrasound Gastrointestinal Videoscope Olympus Gf-UE190

by Olympus Medical Systems Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170410178 UDI-DI Date19 Nov 2025ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Evis Eus Ultrasound Gastrointestinal Videoscope
Generic Name
Flexible ultrasound gastroduodenoscope
Model / Ref / Catalog
OLYMPUS GF-UE190, N6003140
Primary DI / UDI-DI
04953170410178
510(k) Number
FDA Product Code
ODG, ITX
GMDN Term
Flexible ultrasound gastroduodenoscope
Device Class
Class II
Regulation Number
876.1500, 892.1570
GUDID distribution status
In Commercial Distribution

Other devices from Olympus Medical Systems Corporation

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No