VitreJect® Needle; OcuSafe® Needle
FDA 510(k) K230959 · Ocuject, LLC
510(k) numberK230959
Submission
- Device name
- VitreJect® Needle; OcuSafe® Needle
- Applicant
- Ocuject, LLC
Newport Beach, CA, US - Received
- April 4, 2023
- Decision date
- September 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleQNS · Special | 10/25/2024SE |
| K233343 | SteriCap Safety Needle; VitreJect Safety NeedleFMI · Abbreviated | 11/27/2023SE |
| K230372 | VitreJect SyringeQLY · Traditional | 09/08/2023SE |
| K212544 | MiniLoad SyringeFMF · Special | 10/13/2021SE |
| K212805 | SteriCap Mini Needle and Standard NeedlesFMI · Special | 09/30/2021SE |
| K202432 | MiniLoad SyringeFMF · Traditional | 02/19/2021SE |
| K170768 | Mini NeedleFMI · Traditional | 07/10/2017SE |
Questions and answers
When was VitreJect® Needle; OcuSafe® Needle cleared by the FDA?
VitreJect® Needle; OcuSafe® Needle (K230959) received a 510(k) decision of Substantially Equivalent on September 14, 2023, 163 days after the submission was received.
What is the product code of K230959?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.