# K972285: Gettig Styrl-Ject Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Gettig Pharmaceutical Instrument Co.
- Decided: Sep 11, 1997 after 84 days
- Product code: EJI (Syringe, Cartridge)
- Device class: 2
- Regulation: 21 CFR 872.6770
- 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 K771205 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851903: Astra Lightweight Stainless Steel Self Aspir/Syrin, Astra Pharmaceutical Products, Inc. (1985) Summary page 1.
- K771205: Hypodermic Syringe, Terumo America, Inc. (1977) Summary page 1.
- K812934: Monoject Prefilled Syringes, Sherwood Medical Co. (1981) Summary page 1.
- (no number) Wyeth Tubex: named in the summary without a submission number

## Indications for use
The indications for use of the device is to inject medicaments subcutaneously, intramuscularly, or via I.V. access ports. This device is intended for all adult patient populations based upon the appropriate needle size selection by the physician or clinician, and is governed by the specific drug being administered. Any pediatric applications is at the discretion of the physician and governed by the specific drug being administered.

Source page: https://510kreport.com/device/K972285
Methodology: https://510kreport.com/methodology