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)

HumaPen Savvio

K-Number: K160668 · 2016-06-03

ApplicantEli Lilly and Company, Inc.
Decision Date2016-06-03
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HumaPen Savvio is a medical device manufactured by Eli Lilly and Company, Inc.. It received FDA 510(k) clearance on 2016-06-03 under approval number K160668. 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 HumaPen Savvio?

HumaPen Savvio is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Eli Lilly and Company, Inc.. The 510(k) number is K160668.

When was HumaPen Savvio approved by the FDA?

HumaPen Savvio received FDA 510(k) clearance on 2016-06-03, under approval number K160668.

What company makes HumaPen Savvio?

HumaPen Savvio is manufactured by Eli Lilly and Company, Inc..

What is the FDA product code for HumaPen Savvio?

The FDA product code for HumaPen Savvio is FMF.

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. 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 SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, 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.

↑