FDA 510(k)

NOVOFINE AUTOCOVER 30G X 8MM

K-Number: K050106 · 2005-03-30

Decision Date2005-03-30

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NOVOFINE AUTOCOVER 30G X 8MM 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 2005-03-30 under 510(k) number K050106. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVOFINE AUTOCOVER 30G X 8MM?

NOVOFINE AUTOCOVER 30G X 8MM is a medical device that received FDA 510(k) clearance on 2005-03-30. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K050106.

When did NOVOFINE AUTOCOVER 30G X 8MM receive FDA 510(k) clearance?

NOVOFINE AUTOCOVER 30G X 8MM received FDA 510(k) clearance on 2005-03-30, under 510(k) number K050106.

Who is the listed applicant for NOVOFINE AUTOCOVER 30G X 8MM?

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 NOVOFINE AUTOCOVER 30G X 8MM?

The FDA product code for NOVOFINE AUTOCOVER 30G X 8MM is FMI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Novo Nordisk, Inc. as applicant

K231255NovoFine® Plus K210258NovoFine K202005NovoFine Plus 32G Tip x 4 mm K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)K162602NovoPen Echo

View all 12 devices →

Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., 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.