510(k) K222906

Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 by Ningbo Maxcon Medical Technology Co., Ltd. — Product Code MMK

K222906 is an FDA 510(k) premarket notification submitted by Ningbo Maxcon Medical Technology Co., Ltd. for the device "Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421". The FDA issued a decision of Substantially Equivalent on June 16, 2023. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Ningbo Maxcon Medical Technology Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2023
Date Received
September 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type