CORAMATE/SPIROTOME SYSTEM
FDA 510(k) clearance K060384 · decided 2006-07-13
Clearance details
- K-number
- K060384
- Device name
- CORAMATE/SPIROTOME SYSTEM
- Applicant
- Medinvents
- Decision
- Substantially Equivalent
- Date received
- 2006-02-14
- Decision date
- 2006-07-13
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hasselt, Limburg, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-p recall (Z-0124-2015) | Cook Medical Incorporated | 2014-10-24 |