# K981889: Worldwide Medical Technologies Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical Technologies, LLC
- Decided: Jul 31, 1998 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Indications for use
The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.

Source page: https://510kreport.com/device/K981889
Methodology: https://510kreport.com/methodology