# K212202: WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System

- Pathway: 510(k) (Traditional)
- Applicant: OTU Medical, Inc.
- Decided: Apr 13, 2022 after 273 days
- Product code: FAJ (Cystoscope 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 K921244 (1992). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193095: Ambu aScope 4 Cysto, Ambu A/S (2020) Summary page 4.

## Most influential descendants
- K231702: WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet (2023), 0 descendants of its own

## Indications for use
WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. 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/K212202
Methodology: https://510kreport.com/methodology