# K151308: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Fiberoptic GmbH
- Decided: Feb 9, 2016 after 267 days
- Product code: FGA (Kit, Nephroscope)
- 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: 2 generations back to K770729 (1977). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994223: Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20, Richard Wolf Medical Instruments Corp. (2000) Summary page 4.

## Most influential descendants
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K243820: Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (2025), 1 descendant of its own
- K261915: Navigator™ Flex Ureteral Access Sheath Set (2026), 0 descendants of its own
- K252572: Prodeon Urethral Sheath System (2025), 0 descendants of its own
- K250128: Single Use Suction-Evacuation Ureteral Access Sheath (2025), 0 descendants of its own

## Indications for use
The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters. The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.

Source page: https://510kreport.com/device/K151308
Methodology: https://510kreport.com/methodology