FDA.reportPublic FDA data

510(k) K232406

Device
KARL STORZ OR1? SCB CONTROL (WU300)
Applicant
Karl Storz SE & CO. KG
510(k) number
K232406
Product code
ODA
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-03
Date received
2023-08-10
Regulation
876.1500
Classification name
Endoscopic Central Control Unit
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K083598KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATIONKARL STORZ Endoscopy-America, Inc.2009-05-29
K080410KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522KARL STORZ Endoscopy-America, Inc.2008-04-09
K070827KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120KARL STORZ Endoscopy-America, Inc.2007-05-22
K051613MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3Olympus Medical Systems Corporation2005-08-15
K041912SCB/VALLEYLAB FORCE FX INTERFACE UNITKARL STORZ Endoscopy-America, Inc.2004-10-25
K020255RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590Richard Wolf Medical Instruments Corp.2002-09-18
K022270MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHAOlympus Optical Co., Ltd.2002-08-14