# K983067: Fine-Ject

- Pathway: 510(k) (Traditional)
- Applicant: Henke Sass Wolf of America, Inc.
- Decided: Oct 30, 1998 after 58 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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) Becton Dickinson and Company “BD PrecisionGlide® Needle”: named in the summary without a submission number
- (no number) TSK STERIJEKT Premium Disposable Hypodermic Needle: named in the summary without a submission number
- (no number) B. Braun STERICAN® Needles: named in the summary without a submission number

## Indications for use
The Henke-Sass Wolf,Disposable Hypodermic Single Lumen Needle is intended to be used for the purpose of injecting fluids into, or withdrawing fluids from parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K983067
Methodology: https://510kreport.com/methodology