Cleared Traditional

K062918 - KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTO...

K062918 is the FDA 510(k) clearance for KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTO... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FBO) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K062918 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Jan 2007
Decision
111d
Days
Class 2
Risk

K062918 is an FDA 510(k) clearance for the KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM. Classified as Cystourethroscope (product code FBO), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on January 17, 2007 after a review of 111 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K062918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date January 17, 2007
Days to Decision 111 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 130d · This submission: 111d
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 14
Devices cleared under the same product code (FBO) and FDA review panel - the closest regulatory comparables to K062918.
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
K243409 · Karl Storz SE & CO. KG · Nov 2024
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
K131364 · KARL STORZ Endoscopy-America, Inc. · Jan 2014
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
K082046 · KARL STORZ Endoscopy-America, Inc. · Oct 2008
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
K061646 · Laserscope · Jun 2006
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660
K011496 · Richard Wolf Medical Instruments Corp. · Aug 2001
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
K972979 · Smith & Nephew, Inc. · Dec 1997