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FDA 510(k)

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

K-Number: K243149 · 2024-12-20

ApplicantCongruence Medical Solutions, LLC
Decision Date2024-12-20
Product CodeQLY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is a medical device manufactured by Congruence Medical Solutions, LLC. It received FDA 510(k) clearance on 2024-12-20 under approval number K243149. 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 Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Congruence Medical Solutions, LLC. The 510(k) number is K243149.

When was Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) approved by the FDA?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) received FDA 510(k) clearance on 2024-12-20, under approval number K243149.

What company makes Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is manufactured by Congruence Medical Solutions, LLC.

What is the FDA product code for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

The FDA product code for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is QLY.

Related Clinical Trials

NCT04528680 Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42082885 Precision Dosing of Vancomycin: A Systematic Review of Population Pharmacokinetics Models and Comparative Evaluation of Software Tools. Clinical pharmacokinetics (2026)

Related Devices (Code: QLY)

K200242StaClear SyringeTribofilm Research, Inc. K230372VitreJect SyringeOcuject, LLC K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc. 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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