Cleared Traditional

LOBSTER AUTO-INJECTOR

K124026 · Scandinavian Health Limited · General Hospital
Sep 2013
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K124026 is an FDA 510(k) clearance for the LOBSTER AUTO-INJECTOR, 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 13, 2013, 259 days after receiving the submission on December 28, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K124026 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2012
Decision Date September 13, 2013
Days to Decision 259 days
Submission Type Traditional
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