Cleared Traditional

Pump In Style

K200508 · Medela, LLC · Obstetrics & Gynecology
Jun 2020
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K200508 is an FDA 510(k) clearance for the Pump In Style, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Medela, LLC (Mchenry, US). The FDA issued a Cleared decision on June 15, 2020, 105 days after receiving the submission on March 2, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K200508 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2020
Decision Date June 15, 2020
Days to Decision 105 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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