FDA 510(k)

BD Contoured Base Pen Needle

K-Number: K182320 · 2018-12-20

Decision Date2018-12-20

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD Contoured Base Pen Needle is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2018-12-20 under approval number K182320. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Contoured Base Pen Needle?

BD Contoured Base Pen Needle is a medical device that received FDA 510(k) clearance on 2018-12-20. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K182320.

When was BD Contoured Base Pen Needle approved by the FDA?

BD Contoured Base Pen Needle received FDA 510(k) clearance on 2018-12-20, under approval number K182320.

What company makes BD Contoured Base Pen Needle?

BD Contoured Base Pen Needle is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Contoured Base Pen Needle?

The FDA product code for BD Contoured Base Pen Needle is FMI.

Other Devices by Becton, Dickinson and Company

K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe K162516BD Pen Needle K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube K151589BD MAX CT/GC/TV, BD MAX INSTRUMENT K151870BD U-500 INSULIN SYRINGE K161553BD SafeAssist

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Related Devices (Code: FMI)

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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.