Cleared Traditional

K011325 - MEDIFIX URETEROSCOPE

K011325 is an FDA 510(k) clearance for MEDIFIX URETEROSCOPE, manufactured by Medifix, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K011325 · Medifix, Inc. · Gastroenterology & Urology device
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Jul 2001
Decision
85d
Days
Class 2
Risk

K011325 is an FDA 510(k) clearance for the MEDIFIX URETEROSCOPE. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Medifix, Inc. (Morton Grove, US). The FDA issued a Cleared decision on July 25, 2001 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011325

510(k) Number K011325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2001
Decision Date July 25, 2001
Days to Decision 85 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
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGB Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K011325.
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
K011849 · Circon Video · Dec 2001
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
K012951 · Circon Video · Nov 2001
DUR-8, MODELS DUR-8
K012925 · Circon Video · Nov 2001
URETEROSCOPES
K003806 · Global Endoscopy, Inc. · Feb 2001
CORTEK URETHEROSCOPE
K000200 · Cortek Endoscopy, Inc. · Mar 2000
URETERO-RENOSCOPE
K992527 · Fiber Imaging Technologies, Inc. · Oct 1999
K011325 · MEDIFIX URETEROSCOPE
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