Panels › Gastroenterology, Urology › Product code ODA · Class 2
Endoscopic Central Control Unit
Regulation 876.1500
0510(k)s in 12 months (18 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ODA
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 5 | 0 |
| Olympus Medical Systems Corporation | 3 | 0 |
| Smith & Nephew | 3 | 0 |
| Olympus Optical Co., Ltd. | 2 | 0 |
| Richard Wolf Medical Instruments Corp. | 2 | 0 |
| Black Diamond Video, Inc. | 1 | 0 |
| Karl Storz SE & CO. KG | 1 | 0 |
| Siemens Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 2023 | K232406 | KARL STORZ OR1 SCB CONTROL (WU300) Karl Storz SE & CO. KG, DE | ODA |
| Sep 6, 2022 | K221929 | Smith+Nephew INTELLIO Tablet Smith+Nephew | ODA |
| May 13, 2021 | K203566 | Tablet Application Smith & Nephew | ODA |
| Feb 27, 2020 | K192876 | INTELLIO Tablet Application Smith & Nephew | ODA |
| Aug 1, 2016 | K153205 | IDSS ForceTriad Control Module Black Diamond Video, Inc. | ODA |
| Jan 12, 2016 | K151282 | core nova Complete Operating Room Endoscopy Richard Wolf Medical Instruments Corp. | ODA |
| Jan 6, 2012 | K111165 | KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE KARL STORZ Endoscopy-America, Inc. | ODA |
| Feb 15, 2011 | K102763 | SYSTEMS INTEGRATION Olympus Medical Systems Corporation | ODA |
| Mar 22, 2010 | K100345 | SYSTEMS INTEGRATION MODEL: ENDOALPHA Olympus Medical Systems Corporation | ODA |
| May 29, 2009 | K083598 | KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION KARL STORZ Endoscopy-America, Inc. | ODA |
| Apr 9, 2008 | K080410 | KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 KARL STORZ Endoscopy-America, Inc. | ODA |
| May 22, 2007 | K070827 | KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 KARL STORZ Endoscopy-America, Inc. | ODA |
| Aug 15, 2005 | K051613 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 Olympus Medical Systems Corporation | ODA |
| Oct 25, 2004 | K041912 | SCB/VALLEYLAB FORCE FX INTERFACE UNIT KARL STORZ Endoscopy-America, Inc. | ODA |
| Sep 18, 2002 | K020255 | RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 Richard Wolf Medical Instruments Corp. | ODA |
| Aug 14, 2002 | K022270 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA Olympus Optical Co., Ltd. | ODA |
| Aug 10, 2000 | K994231 | SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) Siemens Medical Corp. | ODA |
| Aug 21, 1998 | K981993 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA The Olympus Optical Co. | ODA |
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