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FDA 510(k)

BD Plastipak™ Syringe

K-Number: K251350 · 2025-07-29

Decision Date2025-07-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Plastipak™ Syringe is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-07-29 under approval number K251350. 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 BD Plastipak™ Syringe?

BD Plastipak™ Syringe is a medical device that received FDA 510(k) clearance on 2025-07-29. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K251350.

When was BD Plastipak™ Syringe approved by the FDA?

BD Plastipak™ Syringe received FDA 510(k) clearance on 2025-07-29, under approval number K251350.

What company makes BD Plastipak™ Syringe?

BD Plastipak™ Syringe is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Plastipak™ Syringe?

The FDA product code for BD Plastipak™ Syringe is FMF.

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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.