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FDA 510(k)

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

K-Number: K243936 · 2025-04-03

ApplicantStaclear, Inc.
Decision Date2025-04-03
Product CodeQLY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) is the device name listed in this FDA 510(k) record. The listed applicant is Staclear, Inc.. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K243936. 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 2025-04-03. The listed applicant is Staclear, Inc.. The 510(k) number is K243936.

When did StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) receive FDA 510(k) clearance?

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) received FDA 510(k) clearance on 2025-04-03, under 510(k) number K243936.

Who is the listed applicant for StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)?

The FDA 510(k) record lists Staclear, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Staclear, Inc. 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.

K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

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.K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLCK230372VitreJect SyringeOcuject, 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.

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