Cleared Special

Duo Hands-free Breast Pump

K232608 · Medela, LLC · Obstetrics & Gynecology
Apr 2024
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K232608 is an FDA 510(k) clearance for the Duo Hands-free Breast Pump, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Medela, LLC (Mchenry, US). The FDA issued a Cleared decision on April 12, 2024, 228 days after receiving the submission on August 28, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K232608 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2023
Decision Date April 12, 2024
Days to Decision 228 days
Submission Type Special
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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