Cleared Traditional

K994348 - KSEA SCB-RUI

K994348 is an FDA 510(k) clearance for KSEA SCB-RUI, 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 71-day FDA review.

K994348 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
71d
Days
Class 2
Risk

K994348 is an FDA 510(k) clearance for the KSEA SCB-RUI. 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 March 3, 2000 after a review of 71 days - a notably fast clearance 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: 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 Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K994348

510(k) Number K994348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date March 03, 2000
Days to Decision 71 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
60d faster than avg
Panel avg: 131d · This submission: 71d
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 K994348.
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K013709 · Hill-Rom, Inc. · Nov 2001
KSEA SCB-RUI SCO
K003113 · KARL STORZ Endoscopy-America, Inc. · Mar 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · Smith & Nephew, Inc. · Feb 2001
KARL STORZ AUTOCLAVABLE CAMERA HEAD
K994090 · Karl Storz Imaging, Inc. · Feb 2000
KSEA SCBCOM
K992469 · Karl Storz Endoscopy · Oct 1999
FLEXISCOPE IQ 101
K992362 · Schoelly Fiberoptic GmbH · Aug 1999