FDA 510(k)

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)

K-Number: K182387 · 2018-12-17

Decision Date2018-12-17

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2018-12-17 under 510(k) number K182387. 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 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)?

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is a medical device that received FDA 510(k) clearance on 2018-12-17. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K182387.

When did NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) receive FDA 510(k) clearance?

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) received FDA 510(k) clearance on 2018-12-17, under 510(k) number K182387.

Who is the listed applicant for NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)?

The FDA 510(k) record lists Novo Nordisk, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)?

The FDA product code for NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is FMF.

Related Clinical Trials

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.

NCT05515939Evaluating the InPen in Pediatric Type 1 DiabetesACTIVE_NOT_RECRUITING NCT07542886A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy AdultsCOMPLETED NCT07652528CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP TrialNOT_YET_RECRUITING NCT05947916Real Time Continuous Glucose Monitoring System in T2DM With PregnacyRECRUITING NCT06406439DIA:CONN P8(Smart Insulin Pen) Study in Diabetes PatientsCOMPLETED NCT07284511A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood SugarRECRUITING

Other records listing Novo Nordisk, Inc. as applicant

K231255NovoFine® Plus K210258NovoFine K202005NovoFine Plus 32G Tip x 4 mm K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)K162602NovoPen Echo

Related Devices (Code: FMF)

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-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.