Cleared Traditional

Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421

K222906 · Ningbo Maxcon Medical Technology Co., Ltd. · General Hospital
Jun 2023
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K222906 is an FDA 510(k) clearance for the Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421, 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 June 16, 2023, 266 days after receiving the submission on September 23, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K222906 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2022
Decision Date June 16, 2023
Days to Decision 266 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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