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Regenerative
Clinic Guide
Regulation

FDA clearance

Also known as: 510(k) clearance

A device marketing decision commonly associated with FDA’s 510(k) substantial-equivalence pathway.

Source-checked educational compilation · Not independently clinically reviewed

What this means in a clinic conversation

A cleared device has a defined intended use. Clearance of equipment used to prepare or deliver a material should not be read as approval of every treatment performed with it.

A question to bring

What is the device’s clearance number and intended use, and how does that relate to this procedure?

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Related and commonly confused terms

Use the term in context

Sources and editorial context

This definition was compiled from the sources below and has not received independent clinical review. It supports understanding and consultation preparation.

  1. Premarket Notification 510(k) · U.S. Food and Drug AdministrationReference checked 2026-10-02
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