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FDA 510(k)

Willow Generation 3 Breast Pump

K-Number: K230570 · 2023-10-16

ApplicantWillow Innovations, Inc.
Decision Date2023-10-16
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Willow Generation 3 Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Willow Innovations, Inc.. It received FDA 510(k) clearance on 2023-10-16 under 510(k) number K230570. 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 Willow Generation 3 Breast Pump?

Willow Generation 3 Breast Pump is a medical device that received FDA 510(k) clearance on 2023-10-16. The listed applicant is Willow Innovations, Inc.. The 510(k) number is K230570.

When did Willow Generation 3 Breast Pump receive FDA 510(k) clearance?

Willow Generation 3 Breast Pump received FDA 510(k) clearance on 2023-10-16, under 510(k) number K230570.

Who is the listed applicant for Willow Generation 3 Breast Pump?

The FDA 510(k) record lists Willow Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Willow Generation 3 Breast Pump?

The FDA product code for Willow Generation 3 Breast Pump is HGX.

Other records listing Willow Innovations, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213311Lucy Breast Pump

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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