510(k) K022270
- Device
- MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
- Applicant
- OLYMPUS OPTICAL CO., LTD.
- 510(k) number
- K022270
- Product code
- ODA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-08-14
- Date received
- 2002-07-15
- Regulation
- 876.1500
- Classification name
- Endoscopic Central Control Unit
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURA STORMS-TYLER
- Address
- Two Corporate Center Dr. Melville NY US 11747 11747
FDA Registration Numbers#
- 9611102
- 2020550
- 8010047
- 9610617
- 3014342096
- 3007336750
- 1643264
- 3038718579
- 3010707607
- 3013319212
- 9614434
- 3011050570
- 3003604053
- 9615050
- 3010202439
- 3002808148
Source Documents#
Other 510(k) Records For Product Code ODA #
| 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 |
Legacy Summary#
summary
FDA Review#
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