Cleared Traditional

Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)

K222905 · Ningbo Maxcon Medical Technology Co., Ltd. · General Hospital

Jun 2023

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K222905 is an FDA 510(k) clearance for the Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324), 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 1, 2023, 251 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	K222905 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2022
Decision Date	June 01, 2023
Days to Decision	251 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF