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FDA 510(k)

BD Pen Needle

K-Number: K162516 · 2016-12-09

ApplicantBecton, Dickinson and Company
Decision Date2016-12-09
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K162516. 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 Pen Needle?

BD Pen Needle is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K162516.

When did BD Pen Needle receive FDA 510(k) clearance?

BD Pen Needle received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162516.

Who is the listed applicant for BD Pen Needle?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Pen Needle?

The FDA product code for BD Pen Needle is FMI.

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Other records listing Becton, Dickinson and Company as applicant

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Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen NeedleSandstone Medical (Suzhou), Inc.K253047PRESSONE™Nipro Medical Corporation

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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