FDA Product Code
FDA Product Code ODA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232406 | KARL STORZ OR1 SCB CONTROL (WU300) | Karl Storz SE & CO. KG | 2023-10-03 | Traditional | PDF ↗ |
| K221929 | Smith+Nephew INTELLIO Tablet | Smith+Nephew | 2022-09-06 | Traditional | PDF ↗ |
| K203566 | Tablet Application | Smith & Nephew | 2021-05-13 | Traditional | PDF ↗ |
| K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020-02-27 | Traditional | PDF ↗ |
| K153205 | IDSS ForceTriad Control Module | Black Diamond Video, Inc. | 2016-08-01 | Traditional | PDF ↗ |
| K151282 | core nova Complete Operating Room Endoscopy | Richard Wolf Medical Instruments Corp. | 2016-01-12 | Traditional | PDF ↗ |
| K111165 | KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE | KARL STORZ Endoscopy-America, Inc. | 2012-01-06 | Special | PDF ↗ |
| K102763 | SYSTEMS INTEGRATION | Olympus Medical Systems Corporation | 2011-02-15 | Special | PDF ↗ |
| K100345 | SYSTEMS INTEGRATION MODEL: ENDOALPHA | Olympus Medical Systems Corporation | 2010-03-22 | Special | PDF ↗ |
| K083598 | KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION | KARL STORZ Endoscopy-America, Inc. | 2009-05-29 | Traditional | PDF ↗ |
| K080410 | KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 | KARL STORZ Endoscopy-America, Inc. | 2008-04-09 | Traditional | PDF ↗ |
| K070827 | KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 | KARL STORZ Endoscopy-America, Inc. | 2007-05-22 | Traditional | PDF ↗ |
| K051613 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 | Olympus Medical Systems Corporation | 2005-08-15 | Special | PDF ↗ |
| K041912 | SCB/VALLEYLAB FORCE FX INTERFACE UNIT | KARL STORZ Endoscopy-America, Inc. | 2004-10-25 | Traditional | PDF ↗ |
| K020255 | RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 | Richard Wolf Medical Instruments Corp. | 2002-09-18 | Traditional | PDF ↗ |
| K022270 | MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | Olympus Optical Co., Ltd. | 2002-08-14 | Special | PDF ↗ |
| K994231 | SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) | Siemens Medical Corp. | 2000-08-10 | Traditional | PDF ↗ |
| K981993 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | The Olympus Optical Co. | 1998-08-21 | Traditional | PDF ↗ |
Product code ODA · Class II · Gastroenterology, Urology. Data: openFDA.