Cleared Special

K243409 - KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)

K243409 is an FDA 510(k) clearance for KARL STORZ Pediatric Cysto-Urethro-Fibe..., manufactured by Karl Storz SE & CO. KG. The device is a Class 2 Gastroenterology & Urology device with product code FBO cleared through the Special 510(k) pathway after a 26-day FDA review.

K243409 · Karl Storz SE & CO. KG · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
26d
Days
Class 2
Risk

K243409 is an FDA 510(k) clearance for the KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1). Classified as Cystourethroscope (product code FBO), Class II - Special Controls.

Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on November 27, 2024 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K243409

510(k) Number K243409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2024
Decision Date November 27, 2024
Days to Decision 26 days
Submission Type Special
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
105d faster than avg
Panel avg: 131d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 18
Devices cleared under the same product code (FBO) and FDA review panel - the closest regulatory comparables to K243409.
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1)
K244001 · Karl Storz SE & CO. KG · May 2025
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
ANCHORAGE SCOPE, MODEL 000003
K080780 · Epitek, Inc. · Jul 2008
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
K062918 · KARL STORZ Endoscopy-America, Inc. · Jan 2007
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
K061646 · Laserscope · Jun 2006
K243409 · KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
Download PDF FDA Summary Karl Storz SE & CO. KG