Skip to content

Visera Cysto-Nephro Videoscope Olympus Cyf Type V2R

by Olympus Medical Systems Corporation United States GUDID

Product code FAJ

Regulatory status

as of 24 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170411212 UDI-DIDate29 Jul 2019ListedStatusIn distribution

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 America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

5 recalls · 5 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0689-2024 FDA Class II initiated 4 Dec 2023
    • Ongoing Z-0691-2024 FDA Class II initiated 4 Dec 2023
    • Ongoing Z-0690-2024 FDA Class II initiated 4 Dec 2023
    • Ongoing Z-0692-2024 FDA Class II initiated 4 Dec 2023

    Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

    • Ongoing Z-0331-2024 FDA Class II initiated 25 Sep 2023

    Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Specification

GUDID · synced 22 Oct 2026

Trade Name
Visera Cysto-Nephro Videoscope
Generic Name
Flexible video cystonephroscope, reusable
Model / Ref / Catalog
OLYMPUS CYF TYPE V2R, N6005830
Primary DI / UDI-DI
04953170411212
510(k) Number
FDA Product Code
FAJ
GMDN Term
Flexible video cystonephroscope, reusable
Device Class
Class II
Regulation Number
876.1500
Commercial Distribution
In Commercial Distribution

Related devices

Category: Flexible video cystonephroscope, reusable

Cleared under the same submission (K221683)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • FDA UDI caee2631-d3b7-45b2-96ad-5471a1b5a15d 36 fields · synced 22 Oct 2026