RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108
FDA 510(k) clearance K052506 · decided 2005-10-06
Clearance details
- K-number
- K052506
- Device name
- RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108
- Applicant
- Rubicor Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-13
- Decision date
- 2005-10-06
- 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
+ Add to Predicate Builder ◉ Watch Rubicor Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |