510(k) K150169 ยท KNW Instrument, Biopsy
Sertera Biopsy Device
| Applicant | Hologic, Inc., Malborough MA, US |
| Decision | Substantially Equivalent, Aug 14, 2015 |
| Received | Jan 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150169
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2025 | Hologic, Inc Brand Name: Sertera Biopsy Device
Product Name: Sertera Biopsy Device
Model/Catalog Number: Sertera-14
Software Version: N/A
Product Description: Instrument, Biopsy
Component: N/A Open, Classified |
KNW | None listed |
| Jun 29, 2023 | Hologic, Inc Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast
REF: SERTERA-14 Open, Classified |
KNW | None listed |
| Sep 21, 2016 | Hologic, Inc Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.