Cleared Traditional

K232370 - Percutaneous Nephroscope System

K232370 is the FDA 510(k) clearance for Percutaneous Nephroscope System by Karl Storz SE & CO. KG. It is a Class 2 Gastroenterology & Urology device (product code FGA) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K232370 · Karl Storz SE & CO. KG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
267d
Days
Class 2
Risk

K232370 is an FDA 510(k) clearance for the Percutaneous Nephroscope System. Classified as Kit, Nephroscope (product code FGA), Class II - Special Controls.

Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on May 1, 2024 after a review of 267 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Karl Storz SE & CO. KG devices

Submission Details

510(k) Number K232370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2023
Decision Date May 01, 2024
Days to Decision 267 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 130d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGA Kit, Nephroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGA Kit, Nephroscope

Devices cleared under the same product code (FGA) and FDA review panel - the closest regulatory comparables to K232370.
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
K072594 · Gyrus Acmi, Inc. · Dec 2007
NEPHROSCOPE, 12 DEGREES
K994223 · Richard Wolf Medical Instruments Corp. · Jun 2000
KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
K950433 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
K940594 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
K853486 · Olympus Corp. · Sep 1985
PYELOSCOPE SYSTEM
K770729 · Richard Wolf Medical Instruments Corp. · Apr 1977