FDA 510(k)

Okamoto 002 Lubricated Polyurethane Male Condom

K-Number: K203541 · 2022-02-25

Decision Date2022-02-25

Product CodeMOL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Okamoto 002 Lubricated Polyurethane Male Condom is a medical device manufactured by Okamoto USA, Inc.. It received FDA 510(k) clearance on 2022-02-25 under approval number K203541. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Okamoto 002 Lubricated Polyurethane Male Condom?

Okamoto 002 Lubricated Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by Okamoto USA, Inc.. The 510(k) number is K203541.

When was Okamoto 002 Lubricated Polyurethane Male Condom approved by the FDA?

Okamoto 002 Lubricated Polyurethane Male Condom received FDA 510(k) clearance on 2022-02-25, under approval number K203541.

What company makes Okamoto 002 Lubricated Polyurethane Male Condom?

Okamoto 002 Lubricated Polyurethane Male Condom is manufactured by Okamoto USA, Inc..

What is the FDA product code for Okamoto 002 Lubricated Polyurethane Male Condom?

The FDA product code for Okamoto 002 Lubricated Polyurethane Male Condom is MOL.

Other Devices by Okamoto USA, Inc.

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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.