Cleared Traditional

K940983 - THE KARL STORZ UROMAT(TM)

K940983 is an FDA 510(k) clearance for THE KARL STORZ UROMAT(TM), manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LJH cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K940983 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
203d
Days
Class 2
Risk

K940983 is an FDA 510(k) clearance for the THE KARL STORZ UROMAT(TM). Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 203 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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.

FDA 510(k) Submission Details - K940983

510(k) Number K940983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1994
Decision Date September 20, 1994
Days to Decision 203 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
72d slower than avg
Panel avg: 131d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJH Device Classification - Class 2, Special Controls

Product Code LJH System, Irrigation, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - LJH System, Irrigation, Urological

All 29
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K940983.
SURGACTIVATOR
K951569 · Deschutes Medical Products, Inc. · Jun 1995
URO-FLO
K945140 · Mallinckrodt Group, Inc. · Mar 1995
KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP
K945210 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
PRO PULSE SYRINGE IRRIGATION SYSTEM
K941385 · Giesy Consultants, Inc. · Jun 1994
FILLING VOLUME OPTION
K882295 · Eris Medical Technology · Sep 1988
STERILE FLUID PRODUCING UNIT #EP550
K832040 · American Cystocope Makers, Inc. · Sep 1983
K940983 · THE KARL STORZ UROMAT(TM)
Download PDF FDA Summary KARL STORZ Endoscopy-…