510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Percutaneous Nephroscope System

K232370510(k) TraditionalCleared May 1, 2024267-day reviewClass II21 CFR 876.1500Recalls 8

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Karl Storz SE & CO. KG · FGA Kit, Nephroscope

Cleared on May 1, 2024 as substantially equivalent to K940594 (KARL STORZ Endoscopy-America, Inc., 1994) after a 267-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 8 times.

Decided
May 1, 2024
Review
267 days
Class
Class II
Product code
FGA
Recalls
8
Predicates
1

Its longest line of descent runs back 1 generation to K940594 (1994). No later device cites it as a predicate yet.

K940594 · Karl Storz Adult & Pediatric Nephroscope · KARL STORZ Endoscopy-America, Inc. · 199419901995200020052010201520202025
K940594 · Karl Storz Adult & Pediatric Nephroscope · KARL STORZ Endoscopy-America, Inc. · 19940
  1. Root · 1 generation backK940594 Karl Storz Adult & Pediatric NephroscopeKARL STORZ Endoscopy-America, Inc. · 1994
  2. This deviceK232370 Percutaneous Nephroscope SystemKarl Storz SE & CO. KG · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K940594Karl Storz Adult & Pediatric NephroscopeKARL STORZ Endoscopy-America, Inc.1994—
0 (this device)K232370Percutaneous Nephroscope SystemKarl Storz SE & CO. KG2024—
FIG. 1 — Lineage of K232370, 1994–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K940594Karl Storz Adult & Pediatric Nephroscope
Summary page 5
…Regulatory Class: II Product Code: FGA Classification Gastroenterology/Urology Panel: Predicate KARL STORZ Adult and Pediatric Nephroscope (K940594) Device(s): Device The Percutaneous Nephroscope System consists of the following: Description: - Minim…
KARL STORZ Endoscopy-America, Inc.1994—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 23, 2024Class IIZ-3218-2024Process designVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Jul 23, 2024Class IIZ-3220-2024Process designVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Jul 23, 2024Class IIZ-3219-2024Process designVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Jul 23, 2024Class IIZ-3221-2024Process designVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Jul 23, 2024Class IIZ-3225-2024Process designVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Jul 23, 2024Class IIZ-3224-2024Process designVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Jul 23, 2024Class IIZ-3222-2024Process designVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Jul 23, 2024Class IIZ-3223-2024Process designVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All FGA devices

FGA Kit, Nephroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · FGA

1in 2024

2007: 12016: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGA

Too few FGA 510(k)s in any year since 2007 to give a median.

Recalls per year · FGA

No recall names FGA since 2007.

Adverse event reports per year · FGA

36in 2025

2013: 22015: 12016: 22018: 12019: 12020: 62022: 12023: 112024: 232025: 36
2007high 36 (2025) · low 0 (2007)2025

MAUDE reports naming product code FGA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—02
20140—00
20150—01
20161—02
20170—00
20180—01
20190—01
20200—06
20210—00
20220—01
20230—011
20241—023
20250—036
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Karl Storz SE & CO. KG

33 FDA decisions under this applicant name. See the company

  • K260581KARL STORZ Flexible Video Neuro-EndoscopeKarl Storz SE & CO. KG · 2026
  • K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver…Karl Storz SE & CO. KG · 2026
  • K254303Karl Storz SupraloopKarl Storz SE & CO. KG · 2026
  • K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION…Karl Storz SE & CO. KG · 2026

Recent decisions in FGA

The FGA category page

  • K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH · 2016
  • K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
  • K994223Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View…Richard Wolf Medical Instruments Corp. · 2000
  • K950433Karl Storz Endopyelotomy Set for Endoscopic Urology ProceduresKARL STORZ Endoscopy-America, Inc. · 1995
  • K940594Karl Storz Adult & Pediatric NephroscopeKARL STORZ Endoscopy-America, Inc. · 1994

https://510kreport.com/device/K232370 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232370: Percutaneous Nephroscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232370

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026