# K160316: SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles

- Pathway: 510(k) (Traditional)
- Applicant: M.D.L. S.R.L.
- Decided: Oct 27, 2016 after 265 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922939 (1993). 6 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934371: Bip Multi Modification, Bip USA, Inc. (1994) Summary page 5.
- K960064: Temno Achieve Biopsy Needle, Bauer Medical, Inc. (1996) Summary page 5.
- K141552: Achieve Programmable Auomated Biopsy Systems, Care Fusion (2014) Summary page 5.
- K002947: Biomol Aspiration Biopsy Needle, H.S. Hospital Service S.R.L. (2000) Summary page 5.

## Most influential descendants
- K212820: Disposable Semi Automatic Biopsy Instrument (2022), 0 descendants of its own
- K212822: Disposable Coaxial Biopsy Needle (2022), 0 descendants of its own
- K212819: Disposable Biopsy Refill Needle (2022), 0 descendants of its own
- K214063: Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle (2022), 0 descendants of its own

## Recalls of this device
- Aug 5, 2021 · Class II · Z-2492-2021: Sterility assurance may be compromised.

## Indications for use
SemiCut Semi-Automatic Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. Themy Automatic Biopsy Needle is intended for obtaining core biopsy samples from soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Themy Automatic Biopsy Needle is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the abnormality. Palium Automatic Reusable Biopsy Device is intended for use in obtaining core biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The device is not intended for use in bone. EasyCut Semi-Automatic Biopsy Needle is intended for soft tissue biopsy or aspiration. The device is not intended for use in bone. MDL Biopsy Needle is intended for soft tissue core biopsy with Palium Reusable Automatic Biopsy Device. The device is not intended for use in bone. Coaxial Introducer Needle is intended for use with biopsy devices cannula during soft tissue core biopsy procedures. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Source page: https://510kreport.com/device/K160316
Methodology: https://510kreport.com/methodology