ODA — Endoscopic Central Control Unit Class II

FDA Device Classification

Classification Details

Product Code
ODA
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232406karl storz se and co. kgKARL STORZ OR1™ SCB CONTROL (WU300)October 3, 2023
K221929smith+nephewSmith+Nephew INTELLIO TabletSeptember 6, 2022
K203566smith and nephewTablet ApplicationMay 13, 2021
K192876smith and nephewINTELLIO Tablet ApplicationFebruary 27, 2020
K153205black diamond videoIDSS ForceTriad Control ModuleAugust 1, 2016
K151282richard wolf medical instrumentscore nova Complete Operating Room EndoscopyJanuary 12, 2016
K111165karl storz endoscopy-americaKARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULEJanuary 6, 2012
K102763olympus medical systems corporationSYSTEMS INTEGRATIONFebruary 15, 2011
K100345olympus medical systems corporationSYSTEMS INTEGRATION MODEL: ENDOALPHAMarch 22, 2010
K083598karl storz endoscopy-americaKARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATIONMay 29, 2009
K080410karl storz endoscopy-americaKARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522April 9, 2008
K070827karl storz endoscopy-americaKARL STORZ SCB INTERFACE CONTROL, MODEL 20090120May 22, 2007
K051613olympus medical systems corporationMODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOAugust 15, 2005
K041912karl storz endoscopy-americaSCB/VALLEYLAB FORCE FX INTERFACE UNITOctober 25, 2004
K020255richard wolf medical instrumentsRIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590September 18, 2002
K022270olympus optical coMODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHAAugust 14, 2002
K994231siemens medicalSIEMENS INTEGRATED OPERATING SYSTEM (SIOS)August 10, 2000
K981993olympus opticalOLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHAAugust 21, 1998