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FDA 510(k)

Freestyle Flex

K-Number: K191653 · 2019-10-17

ApplicantMedela AG
Decision Date2019-10-17
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Freestyle Flex is a medical device manufactured by Medela AG. It received FDA 510(k) clearance on 2019-10-17 under approval number K191653. 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 Flex?

Freestyle Flex is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by Medela AG. The 510(k) number is K191653.

When was Freestyle Flex approved by the FDA?

Freestyle Flex received FDA 510(k) clearance on 2019-10-17, under approval number K191653.

What company makes Freestyle Flex?

Freestyle Flex is manufactured by Medela AG.

What is the FDA product code for Freestyle Flex?

The FDA product code for Freestyle Flex is HGX.

Other Devices by Medela AG

K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply K153663Vario 8/18/ci K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film K180415Invia White Foam NPWT K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad K182191Invia Abdominal Dressing Kit

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Related Devices (Code: 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.

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