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FDA 510(k)

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

K-Number: K251849 · 2025-11-21

ApplicantStaclear, Inc.
Decision Date2025-11-21
Product CodeQLY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) is a medical device manufactured by Staclear, Inc.. It received FDA 510(k) clearance on 2025-11-21 under approval number K251849. 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 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)?

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Staclear, Inc.. The 510(k) number is K251849.

When was StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) approved by the FDA?

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) received FDA 510(k) clearance on 2025-11-21, under approval number K251849.

What company makes StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)?

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) is manufactured by Staclear, Inc..

What is the FDA product code for StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)?

The FDA product code for StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) is QLY.

Other Devices by Staclear, Inc.

K243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

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 K243322Altaviz Intravitreal SyringeAltaviz, LLC 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.

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