# K210579: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System

- Pathway: 510(k) (Traditional)
- Applicant: OTU Medical, Inc.
- Decided: Jul 22, 2021 after 146 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181977: WiScope Digital Endoscope System, OTU Medical, Inc. (2018) Summary page 4.
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System, Acmi Corporation (2006) Summary page 4.

## Most influential descendants
- K231497: Choledochoscope System (2024), 0 descendants of its own

## Indications for use
WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. WiScope® OM Endoscope System is also intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

Source page: https://510kreport.com/device/K210579
Methodology: https://510kreport.com/methodology