Freestyle Mini Hands-free
K-Number: K253510 · 2026-04-10
ApplicantMedela, LLC
Decision Date2026-04-10
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Freestyle Mini Hands-free is a medical device manufactured by Medela, LLC. It received FDA 510(k) clearance on 2026-04-10 under approval number K253510. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Freestyle Mini Hands-free?
Freestyle Mini Hands-free is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Medela, LLC. The 510(k) number is K253510.
When was Freestyle Mini Hands-free approved by the FDA?
Freestyle Mini Hands-free received FDA 510(k) clearance on 2026-04-10, under approval number K253510.
What company makes Freestyle Mini Hands-free?
Freestyle Mini Hands-free is manufactured by Medela, LLC.
What is the FDA product code for Freestyle Mini Hands-free?
The FDA product code for Freestyle Mini Hands-free is HGX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.