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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 a medical device manufactured by Ocuject, LLC. It received FDA 510(k) clearance on 2024-10-25 under approval 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. It is manufactured by Ocuject, LLC. The 510(k) number is K242956.

When was LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle approved by the FDA?

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

What company makes 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 manufactured by Ocuject, LLC.

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.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06828250 Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD) COMPLETED

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Ocuject, LLC

K170768Mini Needle K212544MiniLoad Syringe K212805SteriCap Mini Needle and Standard Needles K202432MiniLoad Syringe K233343SteriCap Safety Needle; VitreJect Safety Needle K230959VitreJect® Needle; OcuSafe® Needle

View all 8 devices →

Related Devices (Code: QNS)

K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK

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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