Cleared Traditional

PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P (K914106) - FDA 510(k) Clearance

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

K914106 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
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Jan 1992
Decision
119d
Days
Class 2
Risk

K914106 is an FDA 510(k) clearance for the PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on January 10, 1992 after a review of 119 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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K914106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date January 10, 1992
Days to Decision 119 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 130d · This submission: 119d
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 71
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K914106.
THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
K925128 · KARL STORZ Endoscopy-America, Inc. · Aug 1993
BARD 7 FR. FIBER OPTIC ASSEMBLY
K923545 · C.R. Bard, Inc. · Oct 1992
BARD URETEROSCOPE DEFLECTION MODULE
K920750 · C.R. Bard, Inc. · Apr 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