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FDA 510(k)

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle

K-Number: K242956 · 2024-10-25

ApplicantOcuject, LLC
Decision Date2024-10-25
Product CodeQNS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K242956. The device is classified under product code QNS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle?

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Ocuject, LLC. The 510(k) number is K242956.

When did LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle receive FDA 510(k) clearance?

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle received FDA 510(k) clearance on 2024-10-25, under 510(k) number K242956.

Who is the listed applicant for LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle?

The FDA 510(k) record lists Ocuject, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle?

The FDA product code for LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle is QNS.

Other records listing Ocuject, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233343SteriCap Safety Needle; VitreJect Safety NeedleK230959VitreJect® Needle; OcuSafe® NeedleK230372VitreJect SyringeK212544MiniLoad SyringeK212805SteriCap Mini Needle and Standard NeedlesK202432MiniLoad Syringe

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Related Devices (Code: QNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KKK210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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