Cleared Traditional

Solo, Swing Maxi

K210759 · Medela, LLC · Obstetrics & Gynecology
Aug 2021
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K210759 is an FDA 510(k) clearance for the Solo, Swing Maxi, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Medela, LLC (Mchenry, US). The FDA issued a Cleared decision on August 11, 2021, 149 days after receiving the submission on March 15, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K210759 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2021
Decision Date August 11, 2021
Days to Decision 149 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGX — Pump, Breast, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5160

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