LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle— 510(k) K242956

Name: FDA 510(k) clearance K242956
Creator: U.S. Food and Drug Administration
Published: 2024-10-25

Substantially Equivalent

Ocuject, LLC

FDA 510(k) clearance K242956 for LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle, Substantially Equivalent on 2024-10-25. Applicant: Ocuject, LLC. Device class: 2.

Clearance details

Applicant: Ocuject, LLC
Product code: Code QNS
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2024-09-25
Decision date: 2024-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.