# K024120: Modification to Temno Biopsy Needles

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Jan 15, 2003 after 30 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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) Disposable Semi-Automated Temno® Biopsy Device: named in the summary without a submission number

## Most influential descendants
- K080095: Coramate/Spirotome System (2008), 1 descendant of its own
- K190378: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix (2019), 0 descendants of its own
- K080674: Pajunk's Primocut Disposable Biopsy System (2008), 0 descendants of its own

## Indications for use
This biopsy device is used to remove, by cutting, a specimen of tissue for microscopic evaluation.

Source page: https://510kreport.com/device/K024120
Methodology: https://510kreport.com/methodology