Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VitreJect Syringe

K-Number: K230372 · 2023-09-08

ApplicantOcuject, LLC
Decision Date2023-09-08
Product CodeQLY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VitreJect Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K230372. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitreJect Syringe?

VitreJect Syringe is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Ocuject, LLC. The 510(k) number is K230372.

When did VitreJect Syringe receive FDA 510(k) clearance?

VitreJect Syringe received FDA 510(k) clearance on 2023-09-08, under 510(k) number K230372.

Who is the listed applicant for VitreJect Syringe?

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 VitreJect Syringe?

The FDA product code for VitreJect Syringe is QLY.

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.

K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleK233343SteriCap Safety Needle; VitreJect Safety NeedleK230959VitreJect® Needle; OcuSafe® NeedleK212544MiniLoad SyringeK212805SteriCap Mini Needle and Standard NeedlesK202432MiniLoad Syringe

View all 8 devices →

Related Devices (Code: QLY)

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.

K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.K243322Altaviz Intravitreal SyringeAltaviz, LLCK243027Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)Hangzhou Sightnovo Medical Technology Co., Ltd.K243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLCK200242StaClear SyringeTribofilm Research, 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.

↑