# K021525: Topcut

- Pathway: 510(k) (Traditional)
- Applicant: H.S. Hospital Service S.R.L.
- Decided: Jul 12, 2002 after 63 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 its predicate without a number.
- (no number) Automatic Cutting Needle: named in the summary without a submission number

## Indications for use
This device is a disposable biopsy needle and can be used in ..CT, Mammographic Radiographic and Echographic procedures to obtain biopsies of various tissues including those from Prostate, Kidney, Breast and Liver using an automatic device.

Source page: https://510kreport.com/device/K021525
Methodology: https://510kreport.com/methodology