Sertera Biopsy Device
FDA 510(k) clearance K150169 · decided 2015-08-14
Clearance details
- K-number
- K150169
- Device name
- Sertera Biopsy Device
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-01-26
- Decision date
- 2015-08-14
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number recall (Z-1170-2025) | Hologic, Inc | 2025-02-13 |
| Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from so recall (Z-2035-2023) | Hologic, Inc | 2023-06-29 |
| Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. recall (Z-2869-2016) | Hologic, Inc | 2016-09-21 |
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