# K150169: Sertera Biopsy Device

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Aug 14, 2015 after 200 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922939 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960064: Temno Achieve Biopsy Needle, Bauer Medical, Inc. (1996) Summary page 4.
- K922939: Bard Monopty Disposable Core Biopsy Isnt. W/ Cent., C.R. Bard, Inc. (1993) Summary page 4.

## Recalls of this device
- Jan 15, 2025 · Class II · Z-1170-2025: Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
- May 2, 2023 · Class II · Z-2035-2023: The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
- Aug 22, 2016 · Class II · Z-2869-2016: Incorrect label on the Sertera Biopsy Kit

## Indications for use
The Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.

Source page: https://510kreport.com/device/K150169
Methodology: https://510kreport.com/methodology