# K013070: Jamshidi 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. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“KOI30‘7©”).

## Indications for use
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow

Source page: https://510kreport.com/device/K013070
Methodology: https://510kreport.com/methodology