# K241956: Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3,  PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Endoso Life Technology Co., Ltd.
- Decided: Jan 22, 2025 after 203 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.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230200: Single-Use Flexible Ureteroscope, Hunan Vathin Medical Instrument Co., Ltd. (2023) Summary page 5.

## Indications for use
As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.

Source page: https://510kreport.com/device/K241956
Methodology: https://510kreport.com/methodology