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Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063223

by CooperSurgical, Inc.

Identifiers

510(k) Number
K063223 FDA 510(k)
FDA Product Code
HDW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5350 FDA 510(k)
Regulation Number
884.5350 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Milex contraceptive diaphragm is a shallow silicone cup with a flexible rim that is placed over the cervix by the user. It is intended to be used with spermicidal cream or gel to create a barrier that helps prevent pregnancy. The device is offered in Omniflex (flat/coil) and Arcing styles, providing options for fit and comfort.

The diaphragm is classified by the FDA as a Class II device (product code HDW) and received 510(k) clearance (K063223) on 23 January 2008 as substantially equivalent to a predicate device. It is manufactured by CooperSurgical, Inc. and is listed in the FDA’s device registry under the name Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms.

Frequently asked questions

What is the Milex contraceptive diaphragm used for?

The Milex contraceptive diaphragm is a shallow silicone cup with a flexible rim that is placed over the cervix by the user. It is intended to be used with spermicidal cream or gel to create a barrier that helps prevent pregnancy.

How is the Milex diaphragm supplied and what styles are available?

The Milex contraceptive diaphragm is offered in Omniflex (flat/coil) and Arcing styles, providing options for fit and comfort. It is a reusable device designed for multiple uses with proper cleaning and care.

Is the Milex diaphragm sterile and single-use or reusable?

The Milex contraceptive diaphragm is not supplied sterile and is intended for reuse. It must be cleaned according to the manufacturer's instructions before each use and is made of durable silicone for multiple applications over time.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms ..., K063223 FDA 510(k) - MILEX CONTRACEPTIVE DIAPHRAGM, Food and Drug Administration, MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA 510(k) K063223 24 fields · synced Sep 24, 2026