Sertera Biopsy Device— 510(k) K150169
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K150169 for Sertera Biopsy Device, Substantially Equivalent on 2015-08-14. Applicant: Hologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malborough, MA, US
Recent devices under product code KNW
view allMore clearances from Hologic, Inc.
view allAdverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K150169
K-number listed on FDA's recall record- Z-1170-2025 — 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
- Z-2035-2023 — Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
- Z-2869-2016 — Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150169.
Data sourced from openFDA. This site is unofficial and independent of the FDA.