Cleared Traditional

EXELINT SecureTouch Safety Hypodermic Needle

K152183 · Exelint International, Co. · General Hospital
Nov 2015
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K152183 is an FDA 510(k) clearance for the EXELINT SecureTouch Safety Hypodermic Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Exelint International, Co. (Redondo Beach, US). The FDA issued a Cleared decision on November 2, 2015, 89 days after receiving the submission on August 5, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K152183 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2015
Decision Date November 02, 2015
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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