# K013071: Securcut Aspiration Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: H.S. Hospital Services S.P.A.
- Decided: Dec 12, 2001 after 90 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
This device is intended to be used for taking biopsy sample, must be used on soft tissues and can be used in Fluoroscopic, CT and mammographic procedure to obtain biopsies of various tissues, including those from Breast, Kidney, Liver, Prostate, Lung, Bladder, Thyroid, Abdomen and Pancreas

Source page: https://510kreport.com/device/K013071
Methodology: https://510kreport.com/methodology