FDA.reportPublic FDA data

510(k) K243409

Device
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
Applicant
Karl Storz SE & CO. KG
510(k) number
K243409
Product code
FBO
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-27
Date received
2024-11-01
Regulation
876.1500
Classification name
Cystourethroscope
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Thomas Ostrowski
Address
Dr.-Karl-Storz-Straße 34 Tuttlingen DE 78532 78532

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FBO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K244001KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)Karl Storz SE & CO. KG2025-05-02
K131364FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPEKARL STORZ Endoscopy-America, Inc.2014-01-02
K082046KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCOKARL STORZ Endoscopy-America, Inc.2008-10-10
K080780ANCHORAGE SCOPE, MODEL 000003Epitek, Inc.2008-07-30
K062918KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEMKARL STORZ Endoscopy-America, Inc.2007-01-17
K061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESLaserscope2006-06-27
K011496CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660Richard Wolf Medical Instruments Corp.2001-08-10
K972979SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUMSmith & Nephew, Inc.1997-12-11
K962474OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)Olympus America, Inc.1996-12-20
K941992CYSTOSCOPESurgical Technologies, Inc.1995-11-30
K951972CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSCabot Medical Corp.1995-07-21
K945185CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)KARL STORZ Endoscopy-America, Inc.1995-05-03
K934649GALILEO ENDOSCOPESGalileo Electro-Optics Corp.1994-10-13
K943668KSEA CONTINOUS FLOW CYSTOSCOPEKARL STORZ Endoscopy-America, Inc.1994-09-21
K935163CONTINUOUS IRRIGATION CYSTOURETHROSCOPERichard Wolf Medical Instruments Corp.1994-09-07