ODA — Endoscopic Central Control Unit Class II
FDA product code ODA covers "Endoscopic Central Control Unit", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 18 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232406 | karl storz se and co. kg | KARL STORZ OR1 SCB CONTROL (WU300) | October 3, 2023 |
| K221929 | smith+nephew | Smith+Nephew INTELLIO Tablet | September 6, 2022 |
| K203566 | smith and nephew | Tablet Application | May 13, 2021 |
| K192876 | smith and nephew | INTELLIO Tablet Application | February 27, 2020 |
| K153205 | black diamond video | IDSS ForceTriad Control Module | August 1, 2016 |
| K151282 | richard wolf medical instruments | core nova Complete Operating Room Endoscopy | January 12, 2016 |
| K111165 | karl storz endoscopy-america | KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE | January 6, 2012 |
| K102763 | olympus medical systems corporation | SYSTEMS INTEGRATION | February 15, 2011 |
| K100345 | olympus medical systems corporation | SYSTEMS INTEGRATION MODEL: ENDOALPHA | March 22, 2010 |
| K083598 | karl storz endoscopy-america | KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION | May 29, 2009 |
| K080410 | karl storz endoscopy-america | KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 | April 9, 2008 |
| K070827 | karl storz endoscopy-america | KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 | May 22, 2007 |
| K051613 | olympus medical systems corporation | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FO | August 15, 2005 |
| K041912 | karl storz endoscopy-america | SCB/VALLEYLAB FORCE FX INTERFACE UNIT | October 25, 2004 |
| K020255 | richard wolf medical instruments | RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 | September 18, 2002 |
| K022270 | olympus optical co | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | August 14, 2002 |
| K994231 | siemens medical | SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) | August 10, 2000 |
| K981993 | olympus optical | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | August 21, 1998 |