Cleared Traditional

HumaPen Luxura

K142518 · Eli Lilly and Company · General Hospital
Jun 2015
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K142518 is an FDA 510(k) clearance for the HumaPen Luxura, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on June 5, 2015, 270 days after receiving the submission on September 8, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K142518 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2014
Decision Date June 05, 2015
Days to Decision 270 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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