MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
FDA 510(k) clearance K102996 · decided 2011-01-13
Clearance details
- K-number
- K102996
- Device name
- MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
- Applicant
- Medivators Reprocessing Systems
- Decision
- Substantially Equivalent
- Date received
- 2010-10-07
- Decision date
- 2011-01-13
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- FEB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface be recall (Z-2536-2024) | Steris Corporation | 2024-08-08 |
| Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface recall (Z-2537-2024) | Steris Corporation | 2024-08-08 |
| Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface recall (Z-2538-2024) | Steris Corporation | 2024-08-08 |
| Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automa recall (Z-0617-2024) | Steris Corporation | 2023-12-22 |