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FDA 510(k)

CooperSurgical Milex® Pessaries

K-Number: K250438 · 2025-04-11

ApplicantCooperSurgical, Inc.
Decision Date2025-04-11
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CooperSurgical Milex® Pessaries is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K250438. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CooperSurgical Milex® Pessaries?

CooperSurgical Milex® Pessaries is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K250438.

When did CooperSurgical Milex® Pessaries receive FDA 510(k) clearance?

CooperSurgical Milex® Pessaries received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250438.

Who is the listed applicant for CooperSurgical Milex® Pessaries?

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

What is the FDA product code for CooperSurgical Milex® Pessaries?

The FDA product code for CooperSurgical Milex® Pessaries is HHW.

Other records listing CooperSurgical, Inc. as applicant

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Related Devices (Code: HHW)

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.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.K231786Gynethotics™ PessaryCosm Medical

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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