# K974327: Winged Needle Holder

- Pathway: 510(k) (Traditional)
- Applicant: Phx Technologies Corp.
- Decided: Jan 9, 1998 after 52 days
- Product code: FHQ (Holder, Needle, Gastroenterologic)
- Device class: 1
- Regulation: 21 CFR 876.4730
- 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. The FDA summary names its predicate without a number.
- (no number) Removable winged needle holder: named in the summary without a submission number

## Indications for use
This winged needle holder is indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.

Source page: https://510kreport.com/device/K974327
Methodology: https://510kreport.com/methodology