InPen
K-Number: K160629 · 2016-07-26
ApplicantCompanion Medical, Inc.
Decision Date2016-07-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
InPen is a medical device manufactured by Companion Medical, Inc.. It received FDA 510(k) clearance on 2016-07-26 under approval number K160629. 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 InPen?
InPen is a medical device that received FDA 510(k) clearance on 2016-07-26. It is manufactured by Companion Medical, Inc.. The 510(k) number is K160629.
When was InPen approved by the FDA?
InPen received FDA 510(k) clearance on 2016-07-26, under approval number K160629.
What company makes InPen?
InPen is manufactured by Companion Medical, Inc..
What is the FDA product code for InPen?
The FDA product code for InPen is FMF.
Other Devices by Companion Medical, Inc.
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
K152803SUNGSHIM STERILE SINGLE USE INSULIN SYRINGESung Shim Medicare Co., Ltd.
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.