# K232370: Percutaneous Nephroscope System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: May 1, 2024 after 267 days
- Product code: FGA (Kit, Nephroscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940594 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940594: Karl Storz Adult & Pediatric Nephroscope, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 5.

## Recalls of this device
- Jul 23, 2024 · Class II · Z-3218-2024: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Jul 23, 2024 · Class II · Z-3220-2024: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Jul 23, 2024 · Class II · Z-3219-2024: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Jul 23, 2024 · Class II · Z-3221-2024: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Jul 23, 2024 · Class II · Z-3225-2024: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Jul 23, 2024 · Class II · Z-3224-2024: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Jul 23, 2024 · Class II · Z-3222-2024: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Jul 23, 2024 · Class II · Z-3223-2024: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

## Indications for use
Percutaneous System for adults The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults. Percutaneous System for adults and pediatrics The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.

Source page: https://510kreport.com/device/K232370
Methodology: https://510kreport.com/methodology