Cleared Traditional

K933216 - KARL STORZ ENDOSCOPY-AMERICA, INC. (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933216 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Sep 1993
Decision
135d
Days
Class 2
Risk

K933216 is an FDA 510(k) clearance for the KARL STORZ ENDOSCOPY-AMERICA, INC.. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 135 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

Submission Details

510(k) Number K933216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1993
Decision Date September 09, 1993
Days to Decision 135 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
5d slower than avg
Panel avg: 130d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFS Image, Illumination, Fiberoptic, For Endoscope
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.