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FDA 510(k)

StaClear Syringe

K-Number: K200242 · 2020-07-27

ApplicantTribofilm Research, Inc.
Decision Date2020-07-27
Product CodeQLY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

StaClear Syringe is a medical device manufactured by Tribofilm Research, Inc.. It received FDA 510(k) clearance on 2020-07-27 under approval number K200242. 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?

StaClear Syringe is a medical device that received FDA 510(k) clearance on 2020-07-27. It is manufactured by Tribofilm Research, Inc.. The 510(k) number is K200242.

When was StaClear Syringe approved by the FDA?

StaClear Syringe received FDA 510(k) clearance on 2020-07-27, under approval number K200242.

What company makes StaClear Syringe?

StaClear Syringe is manufactured by Tribofilm Research, Inc..

What is the FDA product code for StaClear Syringe?

The FDA product code for StaClear Syringe is QLY.

Related Devices (Code: QLY)

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. 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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