# K981721: C0-Axial Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Inrad
- Decided: Jul 28, 1998 after 74 days
- Product code: KNW (Instrument, Biopsy)
- 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 K940024 (1994). 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)
- K940024: Manan General Purpose Introducer Needle, Manan Medical Products, Inc. (1994) Summary page 1.

## Most influential descendants
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

## Indications for use
The device is used to guide a biopsy needle to the target lesion for obtaining multiple biopsy samples.

Source page: https://510kreport.com/device/K981721
Methodology: https://510kreport.com/methodology