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FDA Clearance of Penis Pumps

The process and importance of verifying FDA clearance for penis pump devices, including the role of the 510(k) pathway and the need for consumers to be aware of misleading marketing claims.

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Jan 17, 2026

How can consumers verify whether a specific penis pump model is FDA-cleared (510(k))?

Verifying whether a specific penis pump (vacuum erection device) model is FDA-cleared via the 510(k) pathway requires a mix of document checks, database searches, and scrutiny of manufacturer claims; ...