# K243894: F88 URE-SD/RD Flexible Ureteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Sg Endoscopy Pte, Ltd.
- Decided: May 2, 2025 after 135 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.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141250: Flexible Video-Uretero-Renoscope System, KARL STORZ Endoscopy-America, Inc. (2014) Summary page 5.

## Indications for use
The F88 URE-SD/RD Flexible Ureteroscope and the F88 Flexible Camera Control Unit are indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K243894
Methodology: https://510kreport.com/methodology