EVOTECH ECR
FDA 510(k) clearance K140977 · decided 2014-12-22
Clearance details
- K-number
- K140977
- Device name
- EVOTECH ECR
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2014-04-16
- Decision date
- 2014-12-22
- Days to decision
- 250 days
- Clearance type
- Traditional
- 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 Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR End recall (Z-1714-2015) | Advanced Sterilization Products | 2015-06-05 |
| EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH recall (Z-1715-2015) | Advanced Sterilization Products | 2015-06-05 |