EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
FDA 510(k) clearance K061899 · decided 2006-10-26
Clearance details
- K-number
- K061899
- Device name
- EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2006-07-03
- Decision date
- 2006-10-26
- Days to decision
- 115 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 & Reprocessor, Product Code 50004 Indicated for use with high le recall (Z-1368-2008) | Advanced Sterilization Products | 2008-08-08 |
| EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with h recall (Z-1369-2008) | Advanced Sterilization Products | 2008-08-08 |