Cleared Traditional

K952482 - KSEA REVERSE VIDEO

K952482 is an FDA 510(k) clearance for KSEA REVERSE VIDEO, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K952482 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
146d
Days
Class 2
Risk

K952482 is an FDA 510(k) clearance for the KSEA REVERSE VIDEO. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on October 23, 1995 after a review of 146 days - within the typical 510(k) review window.

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 Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K952482

510(k) Number K952482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date October 23, 1995
Days to Decision 146 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
15d slower than avg
Panel avg: 131d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 70
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K952482.
S-57 VIDEO IMAGING SYSTEM
K962024 · Del Medical Systems Corp. · Jul 1996
EVIS 140 SYSTEM
K954451 · Olympus America, Inc. · Mar 1996
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
K954734 · The Tulip Mfg. Co. · Nov 1995
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
K944759 · Fujinon, Inc. · Apr 1995
OLYMPUS SWITCHING UNIT MODEL SU-1
K944081 · Olympus America, Inc. · Nov 1994
FUJINON VIDEO LAPAROSCOPE -- MODIFIED
K932312 · Fujinon, Inc. · Feb 1994