Cleared Traditional

K904793 - SURGITEK GRADUATED URETEROSCOPE (MODEL ...

K904793 is the FDA 510(k) clearance for SURGITEK GRADUATED URETEROSCOPE (MODEL ... by Surgitek. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K904793 · Surgitek · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
133d
Days
Class 2
Risk

K904793 is an FDA 510(k) clearance for the SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8). Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), 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

Submission Details

510(k) Number K904793 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
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 130d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FGB Ureteroscope And Accessories, Flexible/rigid

All 81
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K904793.
BARD URETEROSCOPE DEFLECTION MODULE
K920750 · C.R. Bard, Inc. · Apr 1992
PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P
K914106 · Pentax Precision Instrument Corp. · Jan 1992
BARD 3000 PLUS URETEROSCOPY SYSTEM
K911411 · C.R. Bard, Inc. · Apr 1991
BARD SHORT RIGID URETEROSCOPE
K900813 · C.R. Bard, Inc. · May 1990
BARD URETEROSCOPIC DEVICE
K883110 · C.R. Bard, Inc. · Oct 1988
OLYMPUS RIGID URETERORENOSCOPE
K852888 · Olympus Corp. · Aug 1985