# K262552: Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)

- Pathway: 510(k) (Special)
- Applicant: Scivita Medical Technology Co., Ltd.
- Decided: Aug 14, 2026 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: 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)
- K243708: Urology Videoscope System  (Single-use Flexible Ureteroscope:  SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.), Scivita Medical Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis.

Source page: https://510kreport.com/device/K262552
Methodology: https://510kreport.com/methodology