Cleared Abbreviated

WHISPERJECT AUTOINJECTOR

K141384 · Scandinavian Health Limited · General Hospital
Sep 2014
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K141384 is an FDA 510(k) clearance for the WHISPERJECT AUTOINJECTOR, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Scandinavian Health Limited (Deerfield Beach, US). The FDA issued a Cleared decision on September 12, 2014, 108 days after receiving the submission on May 27, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K141384 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2014
Decision Date September 12, 2014
Days to Decision 108 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920