Cleared Traditional

K994223 - NEPHROSCOPE, 12 DEGREES

Also marketed or referenced as:
DIAPHRAGM VALVE IRRIGATION ATTACHMENT NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW NEPHROSCOPE, 20

K994223 is an FDA 510(k) clearance for NEPHROSCOPE, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGA cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K994223 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
173d
Days
Class 2
Risk

K994223 is an FDA 510(k) clearance for the NEPHROSCOPE, 12 DEGREES. Classified as Kit, Nephroscope (product code FGA), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on June 5, 2000 after a review of 173 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K994223

510(k) Number K994223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1999
Decision Date June 05, 2000
Days to Decision 173 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
42d slower than avg
Panel avg: 131d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGA Device Classification - Class 2, Special Controls

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

All 7
Devices cleared under the same product code (FGA) and FDA review panel - the closest regulatory comparables to K994223.
Percutaneous Nephroscope System
K232370 · Karl Storz SE & CO. KG · May 2024
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
K151308 · Schoelly Fiberoptic GmbH · Feb 2016
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
K072594 · Gyrus Acmi, Inc. · Dec 2007
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