Cleared Traditional

K935818 - ENDOSCOPE

K935818 is an FDA 510(k) clearance for ENDOSCOPE, manufactured by Cuda Products Co.. The device is a Class 2 Gastroenterology & Urology device with product code GDB cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K935818 · Cuda Products Co. · Gastroenterology & Urology device
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Jul 1994
Decision
223d
Days
Class 2
Risk

K935818 is an FDA 510(k) clearance for the ENDOSCOPE. Classified as Endoscope, Fiber Optic (product code GDB), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 223 days - an extended review 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: 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 - K935818

510(k) Number K935818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date July 13, 1994
Days to Decision 223 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 131d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDB Device Classification - Class 2, Special Controls

Product Code GDB Endoscope, Fiber Optic
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 - GDB Endoscope, Fiber Optic

Devices cleared under the same product code (GDB) and FDA review panel - the closest regulatory comparables to K935818.
DESIGNS FOR VISION FIBEROPTIC LIGHT
K032283 · Designs For Vision, Inc. · Aug 2003
FLEXSCOPE
K961536 · Matrix Medica, Inc. · Sep 1996
OLYMPUS GF-UM3/EU-M3
K882061 · Olympus Corp. · Nov 1988
FRITCH OPHTHALMIC ENDOSCOPE
K855151 · Regtec · Feb 1986
FOCUSCOPE UNIVERSAL SYSTEM
K843900 · Medical Diagnostics, Ca. · Dec 1984
PENTAX UPPER G.I. FIBERSCOPE, #FG-34
K810007 · Pentax Precision Instrument Corp. · Jan 1981
K935818 · ENDOSCOPE
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