# K994223: Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jun 5, 2000 after 173 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: 1 generation back to K770729 (1977). 1 ancestor in all.
11 later devices descend from it; 3 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770729: Pyeloscope System, Richard Wolf Medical Instruments Corp. (1977) Summary page 1.
- (no number) Fiber Light Operating Laparoscope 4937: named in the summary without a submission number
- (no number) Operating System for Percutaneous Removal of Kidney Stones 27090 / 27092 / 27093: named in the summary without a submission number
- (no number) Rigid Percutaneous Nephroscope MRO-20: named in the summary without a submission number

## Most influential descendants
- K151308: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (2016), 8 descendants of its own
- 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

## Indications for use
The nephroscope, with its accessories, is used, with suction, for the disintegration and removal / extraction of kidney and bladder stones. The stones are removed, under endoscopic control, through percutaneous or transurethal passages, in conjuction with intercorporeal pneumatic, ultrasound, electrohydraulic or laser lithotriptors.

Source page: https://510kreport.com/device/K994223
Methodology: https://510kreport.com/methodology