GO-PEN®
K-Number: K250262 · 2025-04-24
ApplicantGo-Pen Aps
Decision Date2025-04-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
GO-PEN® is a medical device manufactured by Go-Pen Aps. It received FDA 510(k) clearance on 2025-04-24 under approval number K250262. 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 GO-PEN®?
GO-PEN® is a medical device that received FDA 510(k) clearance on 2025-04-24. It is manufactured by Go-Pen Aps. The 510(k) number is K250262.
When was GO-PEN® approved by the FDA?
GO-PEN® received FDA 510(k) clearance on 2025-04-24, under approval number K250262.
What company makes GO-PEN®?
GO-PEN® is manufactured by Go-Pen Aps.
What is the FDA product code for GO-PEN®?
The FDA product code for GO-PEN® 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.