MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
FDA 510(k) clearance K022879 · decided 2002-09-23
Clearance details
- K-number
- K022879
- Device name
- MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
- Applicant
- Sanarus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-30
- Decision date
- 2002-09-23
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 recall (Z-0935-03) | Sanarus Medical Inc | 2003-06-12 |