Cleared Traditional

Pump In Style Advanced, Advanced Personal Double Breastpump

K181937 · Medela, LLC · Obstetrics & Gynecology
Oct 2018
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K181937 is an FDA 510(k) clearance for the Pump In Style Advanced, Advanced Personal Double Breastpump, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Medela, LLC (Mchenry, US). The FDA issued a Cleared decision on October 16, 2018, 89 days after receiving the submission on July 19, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K181937 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2018
Decision Date October 16, 2018
Days to Decision 89 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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