MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
FDA 510(k) clearance K030049 · decided 2003-01-29
Clearance details
- K-number
- K030049
- Device name
- MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
- Applicant
- Rubicor Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-06
- Decision date
- 2003-01-29
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and dis recall (Z-0715-06) | Rubicor Medical | 2006-04-11 |