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 a medical device manufactured by Ocuject, LLC. It received FDA 510(k) clearance on 2023-09-08 under approval 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. It is manufactured by Ocuject, LLC. The 510(k) number is K230372.
When was VitreJect Syringe approved by the FDA?
VitreJect Syringe received FDA 510(k) clearance on 2023-09-08, under approval number K230372.
What company makes VitreJect Syringe?
VitreJect Syringe is manufactured by Ocuject, LLC.
What is the FDA product code for VitreJect Syringe?
The FDA product code for VitreJect Syringe is QLY.
Other Devices by Ocuject, LLC
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K243027Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)Hangzhou Sightnovo Medical Technology Co., Ltd.
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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.