Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2025-04-11 under approval 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. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K250438.

When was CooperSurgical Milex® Pessaries approved by the FDA?

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

What company makes CooperSurgical Milex® Pessaries?

CooperSurgical Milex® Pessaries is manufactured by CooperSurgical, Inc..

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

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

Other Devices by CooperSurgical, Inc.

K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula K170560SAGE Vitrification Kit and SAGE Vitrification Warming Kit K180429Advincula Delineator Uterine Manipulator K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) K191291Wallace Dual Lumen Oocyte Recovery System

View all 17 devices →

Related Devices (Code: HHW)

K153422Panpac Disposable Pessary Fitting SetPanpac Medical Corporation K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation K190277ProVate Vaginal SupportContipi Medical , Ltd. K183468Revive Reusable Bladder SupportRinovum Subsidiary 2, LLC K240798Cntrl+ Bladder Support PessaryCntrl+, Inc. K232677Reia pessaryReia, LLC

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.

↑