Product code ODA
- Device name
- Endoscopic Central Control Unit
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232406 | KARL STORZ OR1™ SCB CONTROL (WU300) | Karl Storz SE & CO. KG | 2023-10-03 |
| K221929 | Smith+Nephew INTELLIO Tablet | Smith+Nephew | 2022-09-06 |
| K203566 | Tablet Application | Smith & Nephew | 2021-05-13 |
| K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020-02-27 |
| K153205 | IDSS ForceTriad Control Module | Black Diamond Video, Inc. | 2016-08-01 |
| K151282 | core nova Complete Operating Room Endoscopy | Richard Wolf Medical Instruments Corp. | 2016-01-12 |
| K111165 | KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE | KARL STORZ Endoscopy-America, Inc. | 2012-01-06 |
| K102763 | SYSTEMS INTEGRATION | Olympus Medical Systems Corporation | 2011-02-15 |
| K100345 | SYSTEMS INTEGRATION MODEL: ENDOALPHA | Olympus Medical Systems Corporation | 2010-03-22 |
| K083598 | KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION | KARL STORZ Endoscopy-America, Inc. | 2009-05-29 |
| K080410 | KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 | KARL STORZ Endoscopy-America, Inc. | 2008-04-09 |
| K070827 | KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 | KARL STORZ Endoscopy-America, Inc. | 2007-05-22 |
| K051613 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 | Olympus Medical Systems Corporation | 2005-08-15 |
| K041912 | SCB/VALLEYLAB FORCE FX INTERFACE UNIT | KARL STORZ Endoscopy-America, Inc. | 2004-10-25 |
| K020255 | RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 | Richard Wolf Medical Instruments Corp. | 2002-09-18 |
| K022270 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | Olympus Optical Co., Ltd. | 2002-08-14 |
| K994231 | SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) | Siemens Medical Corp. | 2000-08-10 |
| K981993 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | The Olympus Optical Co. | 1998-08-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04953170435201 | SYSTEMS INTEGRATION ENDOALPHA | OLYMPUS MEDICAL SYSTEMS CORP. | 2021-12-21 |
| 04953170148040 | Universal display for ENDOALPHA | OLYMPUS MEDICAL SYSTEMS CORP. | 2021-12-16 |
| 04953170391842 | INTERFACE FOR ESU (VIO SERIES) | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-09-16 |
| 04953170391965 | INTERFACE FOR OLYMPUS LINK DEVICE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-09-16 |
| 04953170391903 | UNIVERSAL INTERFACE | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-09-16 |
| 04953170391873 | INTERFACE FOR ESU (FORCE SERIES) | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-09-16 |
| 04953170391804 | EXTENSION UNIT FOR UCES-4 | OLYMPUS MEDICAL SYSTEMS CORP. | 2018-09-16 |
| 04048551228517 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551062265 | KARL STORZ SCB | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551061855 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551061817 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551061336 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551060766 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551013502 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551006740 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551006733 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551006719 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04953170286049 | EXTENSION UNIT FOR UCES-3 | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170286018 | MEDICAL CONTROL UNIT FOR ENDOSURGERY | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170291531 | INTERFACE FOR ESU(FORCE SERIES) | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170286117 | UCR CABLE FOR UCES-3 | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170291494 | INTERFACE FOR OLYMPUS RS-232C DEVICE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170059148 | VTR remote cable | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170291517 | INTERFACE FOR ESU(BIO SERIES) | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170390616 | UPGRADE KIT FOR UCES-3 (Version 7) | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170363016 | UPGRADE KIT FOR UCES-3 (Version 6) | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170352881 | UPGRADE KIT FOR UCES-3 (Version 5) | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170335464 | UPGRADE KIT FOR UCES-3 (Version 4) | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170291579 | IR INTERFACE FOR UCES-3 | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170291555 | UNIVERSAL INTERFACE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |