# K181977: WiScope Digital Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: OTU Medical, Inc.
- Decided: Aug 14, 2018 after 21 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: 9 generations back to K931154 (1993). 25 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171076: Medical Video Endoscope System, Zhuhai Pusen Medical Technology Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K210579: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System (2021), 1 descendant of its own
- K240203: URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) (2024), 0 descendants of its own
- K231497: Choledochoscope System (2024), 0 descendants of its own

## Indications for use
WiScope™ Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. 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/K181977
Methodology: https://510kreport.com/methodology