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FDA Classification of External Penile Rigidity Devices

The FDA has classified external penile rigidity devices as Class II but has determined they are exempt from the premarket notification (510(k)) requirement.

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Jan 17, 2026

Which manufacturers currently hold FDA 510(k) clearances for external penile rigidity devices and what are their 510(k) numbers?

The FDA has classified external penile rigidity devices as Class II but has determined they are exempt from the premarket notification (510(k)) requirement, meaning manufacturers do not need to obtain...