Cleared Traditional

Promisemed Sharps container

K211890 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Nov 2021
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K211890 is an FDA 510(k) clearance for the Promisemed Sharps container, a Container, Sharps (Class II — Special Controls, product code MMK), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on November 17, 2021, 149 days after receiving the submission on June 21, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K211890 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2021
Decision Date November 17, 2021
Days to Decision 149 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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