EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
FDA 510(k) clearance K082392 · decided 2008-11-13
Clearance details
- K-number
- K082392
- Device name
- EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2008-08-19
- Decision date
- 2008-11-13
- Days to decision
- 86 days
- Clearance type
- Special
- Product code
- FEB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR recall (Z-0965-2017) | Advanced Sterilization Products | 2017-01-09 |
| EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically cle recall (Z-1150-2013) | Advanced Sterilization Products | 2013-04-18 |
| EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean recall (Z-1123-2013) | Advanced Sterilization Products | 2013-04-15 |