Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BD Eclipse Hypodermic Needle

K-Number: K161170 · 2016-05-27

ApplicantBecton, Dickinson and Company
Decision Date2016-05-27
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Eclipse Hypodermic Needle is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-05-27 under approval number K161170. 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 Eclipse Hypodermic Needle?

BD Eclipse Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2016-05-27. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K161170.

When was BD Eclipse Hypodermic Needle approved by the FDA?

BD Eclipse Hypodermic Needle received FDA 510(k) clearance on 2016-05-27, under approval number K161170.

What company makes BD Eclipse Hypodermic Needle?

BD Eclipse Hypodermic Needle is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Eclipse Hypodermic Needle?

The FDA product code for BD Eclipse Hypodermic Needle is FMI.

Related Clinical Trials

NCT07540806 Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis NOT_YET_RECRUITING

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

View all 100 devices →

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), 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.

↑