VACUUM ASSISTED CORE BIOPSY DEVICE
FDA 510(k) clearance K010400 · decided 2001-07-24
Clearance details
- K-number
- K010400
- Device name
- VACUUM ASSISTED CORE BIOPSY DEVICE
- Applicant
- Promex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-12
- Decision date
- 2001-07-24
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Franklin, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, recall (Z-2285-2010) | Hologic, Inc. | 2010-08-26 |
| ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part num recall (Z-1160-2010) | Hologic, Inc. | 2010-03-18 |
| ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic recall (Z-0275-2009) | Hologic, Inc. | 2008-11-07 |
| Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a recall (Z-0362-2007) | Suros Surgical Systems Inc. | 2007-01-23 |
| ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref recall (Z-1160-06) | Suros Surgical Systems Inc. | 2006-06-22 |