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510(k) Clearance Process

The FDA's 510(k) clearance process for medical devices, including the requirement for manufacturers to notify the FDA at least 90 days before marketing certain devices.

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Jan 27, 2026
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How can a patient verify whether a specific vacuum erection device is FDA‑cleared (510(k))?

A patient can verify whether a specific vacuum erection device (VED) is ‑cleared by searching the FDA’s public records for the device or manufacturer, checking packaging and labeling for a 510(k) (K) ...