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Orion Plus/Modification

FDA 510(k)

Class II (US FDA 510(k))

510(k) K904840

by Mayer Laboratories

Identifiers

510(k) Number
K904840 FDA 510(k)
FDA Product Code
HIS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5300 FDA 510(k)
Regulation Number
884.5300 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a condom, as defined by its device name and classification. It is a barrier contraceptive device intended for use during sexual intercourse to prevent pregnancy and reduce the risk of sexually transmitted infections.

It is supplied as a single-use, non-sterile product and is regulated as a Class II medical device under FDA 510(k) clearance (K904840). The device is intended for over-the-counter use and does not require sterilization prior to use.

Frequently asked questions

What is the ORION PLUS/MODIFICATION condom used for?

The ORION PLUS/MODIFICATION condom is a barrier contraceptive device intended for use during sexual intercourse to prevent pregnancy and reduce the risk of sexually transmitted infections, as stated in its device description and classification as a condom.

Is the ORION PLUS/MODIFICATION condom sterile or non-sterile, and is it reusable?

The ORION PLUS/MODIFICATION condom is supplied as a single-use, non-sterile product and is not intended for reuse; it is designed for one-time use only and does not require sterilization prior to use, as specified in the device description.

How is the ORION PLUS/MODIFICATION condom supplied and where can it be obtained?

The ORION PLUS/MODIFICATION condom is intended for over-the-counter use, meaning it is available without a prescription and can be purchased directly by consumers for personal use, as indicated in the device description.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mayer Laboratories

Sources (1)

  • FDA 510(k) K904840 24 fields · synced Sep 23, 2026