Atlas FDA

ODA

18 FDA 510(k) clearances · Product code

142 daysmedian time to decision
255 days90th percentile
18clearances measured

FDA profile

Official device name
Endoscopic Central Control Unit
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
Adverse events (MAUDE)
2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
KARL STORZ OR1™ SCB CONTROL (WU300) (K232406)Karl Storz SE & CO. KG2023-10-03
Smith+Nephew INTELLIO Tablet (K221929)Smith+Nephew2022-09-06
Tablet Application (K203566)Smith & Nephew2021-05-13
INTELLIO Tablet Application (K192876)Smith & Nephew2020-02-27
IDSS ForceTriad Control Module (K153205)Black Diamond Video, Inc.2016-08-01
core nova Complete Operating Room Endoscopy (K151282)Richard Wolf Medical Instruments Corp.2016-01-12
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE (K111165)KARL STORZ Endoscopy-America, Inc.2012-01-06
SYSTEMS INTEGRATION (K102763)Olympus Medical Systems Corporation2011-02-15
SYSTEMS INTEGRATION MODEL: ENDOALPHA (K100345)Olympus Medical Systems Corporation2010-03-22
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION (K083598)KARL STORZ Endoscopy-America, Inc.2009-05-29
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 (K080410)KARL STORZ Endoscopy-America, Inc.2008-04-09
KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 (K070827)KARL STORZ Endoscopy-America, Inc.2007-05-22
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 (K051613)Olympus Medical Systems Corporation2005-08-15
SCB/VALLEYLAB FORCE FX INTERFACE UNIT (K041912)KARL STORZ Endoscopy-America, Inc.2004-10-25
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 (K020255)Richard Wolf Medical Instruments Corp.2002-09-18
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (K022270)Olympus Optical Co., Ltd.2002-08-14
SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) (K994231)Siemens Medical Corp.2000-08-10
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (K981993)The Olympus Optical Co.1998-08-21

Track ODA automatically

Every clearance here is in the API, with alerts when new ones post.