Requests that the FDA Issue a Letter to Healthcare Providers, an It Has Come to Our Attention Letter, and a Safety Communication Letter Confirming that the BariClip (B-Clamp) Implantable Gastric Clip Device is Not Authorized For Sale or Marketing, that its Marketing and Promotion are Prohibited, and that Using or Studying the Device Requires a FDA-approved Investigational Device Exemption
🏛 Food and Drug Administration (FDA)FDA-2026-P-5453
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