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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 the device name listed in this FDA 510(k) record. The listed applicant is Eli Lilly and Company, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) 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. The listed applicant is Eli Lilly and Company, Inc.. The 510(k) number is K160668.

When did HumaPen Savvio receive FDA 510(k) clearance?

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

Who is the listed applicant for HumaPen Savvio?

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

What is the FDA product code for HumaPen Savvio?

The FDA product code for HumaPen Savvio is FMF.

Other records listing Eli Lilly and Company, Inc. as applicant

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.

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Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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.

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