# K961185: Daum Biopsyneedle

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Apr 30, 1996 after 35 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
Longest line of descent: 1 generation back to K813338 (1982). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813338: Biopsy Needles & Trays, American Pharmaseal Div. Ahsc (1982) Summary page 1.
- (no number) MD Tech Ultra-Core Biopsy Needle: named in the summary without a submission number

## Most influential descendants
- K963794: Punctureneedle (1998), 0 descendants of its own

## Indications for use
The Daum BiopsyNeedle is intended for use in percutaneous or opcn eurgical biopsies, including but not limited to, biopsy of Dbreast, 1lung, kidney, liver, lymph nodes, and prostate.

Source page: https://510kreport.com/device/K961185
Methodology: https://510kreport.com/methodology