Cleared Traditional

K951995 - KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR

K951995 is an FDA 510(k) clearance for KARL STORZ CATHETERS, manufactured by Karl Storz Endoskop GmbH. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K951995 · Karl Storz Endoskop GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
26d
Days
Class 2
Risk

K951995 is an FDA 510(k) clearance for the KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Karl Storz Endoskop GmbH (Culver City, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 26 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Karl Storz Endoskop GmbH devices

FDA 510(k) Submission Details - K951995

510(k) Number K951995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1995
Decision Date May 24, 1995
Days to Decision 26 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 131d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
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 - KNY Accessories, Catheter, G-u

All 42
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K951995.
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