# K233343: SteriCap Safety Needle; VitreJect Safety Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Ocuject, LLC
- Decided: Nov 27, 2023 after 59 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
Longest line of descent: 6 generations back to K970370 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212805: SteriCap Mini Needle and Standard Needles, Ocuject, LLC (2021) Summary page 4.
- K230959: VitreJect® Needle; OcuSafe® Needle, Ocuject, LLC (2023) Summary page 4.

## Most influential descendants
- K242956: LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (2024), 0 descendants of its own

## Indications for use
The SteriCap Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick. The VitreJect Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect Safety Needle is indicated for intravitreal use. The VitreJect Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.

Source page: https://510kreport.com/device/K233343
Methodology: https://510kreport.com/methodology