Cleared Traditional

K904797 - SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)

K904797 is an FDA 510(k) clearance for SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16), manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with product code FBO cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K904797 · Surgitek · Gastroenterology & Urology device
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Mar 1991
Decision
133d
Days
Class 2
Risk

K904797 is an FDA 510(k) clearance for the SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16). Classified as Cystourethroscope (product code FBO), Class II - Special Controls.

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on March 5, 1991 after a review of 133 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 Surgitek devices

FDA 510(k) Submission Details - K904797

510(k) Number K904797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1990
Decision Date March 05, 1991
Days to Decision 133 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 131d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBO Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (FBO) and FDA review panel - the closest regulatory comparables to K904797.
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
VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE
K870679 · Van-Tec, Inc. · Mar 1987
OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE
K843084 · Olympus Corp. · Jan 1985