Cleared Traditional

Maxcon Sharps Container

K180984 · Ningbo Maxcon Medical Technology Co., Ltd. · General Hospital
Jan 2019
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K180984 is an FDA 510(k) clearance for the Maxcon Sharps Container, a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Ningbo Maxcon Medical Technology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on January 3, 2019, 265 days after receiving the submission on April 13, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K180984 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2018
Decision Date January 03, 2019
Days to Decision 265 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MMK — Container, Sharps
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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