Cleared Traditional

K191653 - Freestyle Flex
(FDA 510(k) Clearance)

K191653 · Medela AG · Obstetrics & Gynecology

Oct 2019

Decision

119d

Days

Class 2

Risk

K191653 is an FDA 510(k) clearance for the Freestyle Flex. This device is classified as a Pump, Breast, Powered (Class II — Special Controls, product code HGX).

Submitted by Medela AG (Baar Zug, CH). The FDA issued a Cleared decision on October 17, 2019, 119 days after receiving the submission on June 20, 2019.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number	K191653 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2019
Decision Date	October 17, 2019
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF