Cleared Traditional

ARTIGLASS L. O.R. GLASS SYRINGE

K122416 · Artiglass Srl · General Hospital

May 2013

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K122416 is an FDA 510(k) clearance for the ARTIGLASS L. O.R. GLASS SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Artiglass Srl (Due Carrare Padova, IT). The FDA issued a Cleared decision on May 3, 2013, 268 days after receiving the submission on August 8, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K122416 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2012
Decision Date	May 03, 2013
Days to Decision	268 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF