Cleared Traditional

BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM

K121270 · Bioject Medical Technologies, Inc. · General Hospital
Jul 2012
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K121270 is an FDA 510(k) clearance for the BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM, a Injector, Fluid, Non-electrically Powered (Class II — Special Controls, product code KZE), submitted by Bioject Medical Technologies, Inc. (Tigard, US). The FDA issued a Cleared decision on July 19, 2012, 84 days after receiving the submission on April 26, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5430.

Submission Details

510(k) Number K121270 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2012
Decision Date July 19, 2012
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZE — Injector, Fluid, Non-electrically Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5430

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