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FDA 510(k)

Merit Syringe

K-Number: K250853 · 2025-11-04

Decision Date2025-11-04
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Merit Syringe is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-11-04 under approval number K250853. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Merit Syringe?

Merit Syringe is a medical device that received FDA 510(k) clearance on 2025-11-04. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K250853.

When was Merit Syringe approved by the FDA?

Merit Syringe received FDA 510(k) clearance on 2025-11-04, under approval number K250853.

What company makes Merit Syringe?

Merit Syringe is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Merit Syringe?

The FDA product code for Merit Syringe is FMF.

Other Devices by Merit Medical Systems, Inc.

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Related Devices (Code: FMF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.