Data / Medical devices / United States / Ocuject, LLC

Ocuject, LLC: FDA-registered device maker in San Diego, CA, United States, 7 510(k) clearances

Name: Ocuject, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ocuject, LLC is registered with the FDA (registration 3012478173) in San Diego, CA, United States. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012478173
Address: 13240 Evening Creek Dr S Ste 304, San Diego, CA, United States, 92128
Owner or operator: OcuJect, LLC (10051392)
Roles: Manufacturer, Specification developer
First device listed: September 1, 2017
Registered through: 2026
Brand names listed: Mini Needle, MiniLoad Syringe, OcuSafe® LDS Needle, SteriCap Mini Needle, SteriCap® LDS Safety Needle, SteriLoad, VitreJect Safety Needle, VitreJect Syringe and more

Devices it lists

Device	Product code	Class	Role	Source
Low Dead Space Needle, Single Lumen, Hypodermic	QNS	2	Specification developer	accessdata.fda.gov
Low Dead Space Piston Syringe	QNQ	2	Specification developer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Specification developer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer, Specification developer	accessdata.fda.gov
Ophthalmic Needle	QYM	2	Specification developer	accessdata.fda.gov
Ophthalmic Syringe	QLY	2	Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 25, 2024	K242956	LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle	QNS	Substantially Equivalent	Ocuject, LLC	accessdata.fda.gov
November 27, 2023	K233343	SteriCap Safety Needle; VitreJect Safety Needle	FMI	Substantially Equivalent	Ocuject, LLC	accessdata.fda.gov
September 14, 2023	K230959	VitreJect® Needle; OcuSafe® Needle	FMI	Substantially Equivalent	Ocuject, LLC	accessdata.fda.gov
September 8, 2023	K230372	VitreJect Syringe	QLY	Substantially Equivalent	Ocuject, LLC	accessdata.fda.gov
October 13, 2021	K212544	MiniLoad Syringe	FMF	Substantially Equivalent	Ocuject, LLC	accessdata.fda.gov
May 7, 2019	K183016	SteriCap Mini Needle	FMI	Substantially Equivalent	Ocujet, LLC	accessdata.fda.gov
July 10, 2017	K170768	Mini Needle	FMI	Substantially Equivalent	Ocuject, LLC	accessdata.fda.gov

Compare with other makers

Updated October 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.