Cleared Traditional

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1) (K244001) - FDA 510(k) Clearance

Also marketed or referenced as:
KARL STORZ Cysto-Urethro-Fiberscope (11272C2)

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

K244001 · Karl Storz SE & CO. KG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
127d
Days
Class 2
Risk

K244001 is an FDA 510(k) clearance for the KARL STORZ Cysto-Urethro-Fiberscope (11272CU1). 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 May 2, 2025 after a review of 127 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 SE & CO. KG devices

Submission Details

510(k) Number K244001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2024
Decision Date May 02, 2025
Days to Decision 127 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
3d faster than avg
Panel avg: 130d · This submission: 127d
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 18
Devices cleared under the same product code (FBO) and FDA review panel - the closest regulatory comparables to K244001.
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
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
K062918 · KARL STORZ Endoscopy-America, Inc. · Jan 2007
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
K972979 · Smith & Nephew, Inc. · Dec 1997
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
K945185 · KARL STORZ Endoscopy-America, Inc. · May 1995