FDA Product Code ODA: Endoscopic Central Control Unit
To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command.
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Olympus Medical Systems Corporation and Smith & Nephew.
18
Total
18
Cleared
134d
Avg days
1998
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Endoscopic Central Control Unit Devices (Product Code ODA)
18 devices
Cleared
Oct 03, 2023
KARL STORZ OR1™ SCB CONTROL (WU300)
Karl Storz SE & CO. KG
General & Plastic Surgery
54d
Cleared
Sep 06, 2022
Smith+Nephew INTELLIO Tablet
Smith & Nephew
General & Plastic Surgery
67d
Cleared
May 13, 2021
Tablet Application
Smith & Nephew
General & Plastic Surgery
157d
Cleared
Feb 27, 2020
INTELLIO Tablet Application
Smith & Nephew
General & Plastic Surgery
142d
Cleared
Jan 12, 2016
core nova Complete Operating Room Endoscopy
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology
243d
Cleared
Jan 06, 2012
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
255d
Cleared
Feb 15, 2011
SYSTEMS INTEGRATION
Olympus Medical Systems Corporation
Gastroenterology & Urology
144d
Cleared
Mar 22, 2010
SYSTEMS INTEGRATION MODEL: ENDOALPHA
Olympus Medical Systems Corporation
Gastroenterology & Urology
45d
Cleared
May 29, 2009
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
175d
Cleared
Apr 09, 2008
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
55d
Cleared
May 22, 2007
KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
57d
Cleared
Aug 15, 2005
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3
Olympus Medical Systems Corporation
Gastroenterology & Urology
59d
Cleared
Oct 25, 2004
SCB/VALLEYLAB FORCE FX INTERFACE UNIT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
102d
Cleared
Sep 18, 2002
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology
237d
About Product Code ODA - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code ODA since 1998, with 18 receiving FDA clearance (average review time: 134 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.