Cleared Traditional

K933216 - KARL STORZ ENDOSCOPY-AMERICA, INC.

K933216 is an FDA 510(k) clearance for KARL STORZ ENDOSCOPY-AMERICA, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFS cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K933216 · 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 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.

FDA 510(k) Submission Details - K933216

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 131d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FFS Image, Illumination, Fiberoptic, For Endoscope

All 25
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K933216.
LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR
K944688 · Progressive Dynamics, Inc. · Nov 1994
LIQUID LIGHT 500
K940962 · Incredivision, Inc. · Apr 1994
XENON LIGHT SOURCE
K940963 · Incredivision, Inc. · Apr 1994
FIBER OPTIC LIGHT TRANSMISSION CABLE
K892145 · Opto Vision, Inc. · Sep 1989
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
K893440 · Welch Allyn, Inc. · Jul 1989
LIGHT SOURCE, ENDOSCOP, XENON ARC
K890448 · Mira, Inc. · May 1989
K933216 · KARL STORZ ENDOSCOPY-AMERICA, INC.
Download PDF FDA Summary KARL STORZ Endoscopy-…