Cleared Traditional

GALILEO ENDOSCOPES (K934649) - FDA 510(k) Clearance

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

K934649 · Galileo Electro-Optics Corp. · Gastroenterology & Urology device
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Oct 1994
Decision
379d
Days
Class 2
Risk

K934649 is an FDA 510(k) clearance for the GALILEO ENDOSCOPES. Classified as Cystourethroscope (product code FBO), Class II - Special Controls.

Submitted by Galileo Electro-Optics Corp. (Sturbridge, US). The FDA issued a Cleared decision on October 13, 1994 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Galileo Electro-Optics Corp. devices

Submission Details

510(k) Number K934649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date October 13, 1994
Days to Decision 379 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
249d slower than avg
Panel avg: 130d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBO Cystourethroscope
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 - FBO Cystourethroscope

All 12
Devices cleared under the same product code (FBO) and FDA review panel - the closest regulatory comparables to K934649.
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
K972979 · Smith & Nephew, Inc. · Dec 1997
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
K962474 · Olympus America, Inc. · Dec 1996
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
K945185 · KARL STORZ Endoscopy-America, Inc. · May 1995
KSEA CONTINOUS FLOW CYSTOSCOPE
K943668 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
CONTINUOUS IRRIGATION CYSTOURETHROSCOPE
K935163 · Richard Wolf Medical Instruments Corp. · Sep 1994
OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE
K843084 · Olympus Corp. · Jan 1985