FDA 510(k)

Altaviz Intravitreal Syringe

K-Number: K243322 · 2025-05-09

Decision Date2025-05-09

Product CodeQLY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Altaviz Intravitreal Syringe is a medical device manufactured by Altaviz, LLC. It received FDA 510(k) clearance on 2025-05-09 under approval number K243322. 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 Altaviz Intravitreal Syringe?

Altaviz Intravitreal Syringe is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by Altaviz, LLC. The 510(k) number is K243322.

When was Altaviz Intravitreal Syringe approved by the FDA?

Altaviz Intravitreal Syringe received FDA 510(k) clearance on 2025-05-09, under approval number K243322.

What company makes Altaviz Intravitreal Syringe?

Altaviz Intravitreal Syringe is manufactured by Altaviz, LLC.

What is the FDA product code for Altaviz Intravitreal Syringe?

The FDA product code for Altaviz Intravitreal Syringe is QLY.

Other Devices by Altaviz, LLC

K222681Altaviz Needle Kit K231261Altaviz Needle Kit II

Related Devices (Code: QLY)

K200242StaClear SyringeTribofilm Research, Inc. K230372VitreJect SyringeOcuject, LLC K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLC K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc. K243027Disposable 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.

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.