FDA 510(k) Applications for Medical Device Product Code "ODA"
(Endoscopic Central Control Unit)

FDA 510(k) Number Applicant Device Name Decision Date
K153205 BLACK DIAMOND VIDEO, INC IDSS ForceTriad Control Module 08/01/2016
K111165 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE 01/06/2012
K070827 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 05/22/2007
K080410 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 04/09/2008
K083598 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION 05/29/2009
K041912 KARL STORZ ENDOSCOPY-AMERICA, INC. SCB/VALLEYLAB FORCE FX INTERFACE UNIT 10/25/2004
K232406 Karl Storz SE & Co. KG KARL STORZ OR1Ö SCB CONTROL (WU300) 10/03/2023
K051613 OLYMPUS MEDICAL SYSTEMS CORPORATION MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 08/15/2005
K102763 OLYMPUS MEDICAL SYSTEMS CORPORATION SYSTEMS INTEGRATION 02/15/2011
K100345 OLYMPUS MEDICAL SYSTEMS CORPORATION SYSTEMS INTEGRATION MODEL: ENDOALPHA 03/22/2010
K022270 OLYMPUS OPTICAL CO., LTD. MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA 08/14/2002
K151282 RICHARD WOLF MEDICAL INSTRUMENTS CORP. core nova Complete Operating Room Endoscopy 01/12/2016
K020255 RICHARD WOLF MEDICAL INSTRUMENTS CORP. RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 09/18/2002
K994231 SIEMENS MEDICAL CORP. SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) 08/10/2000
K192876 Smith & Nephew INTELLIO Tablet Application 02/27/2020
K203566 Smith & Nephew Tablet Application 05/13/2021
K221929 Smith+Nephew Smith+Nephew INTELLIO Tablet 09/06/2022
K981993 THE OLYMPUS OPTICAL CO. OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA 08/21/1998


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