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Nonrulemaking
FDA
Open for Comments
FDA-2026-P-5453
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
Documents
5
Comments
0
Description
Open
Key Dates
Comment Period OpensMay 13, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Keywords
CDRH
Citizen Petition
Harmed Americans for Reform in
Medical-Device Safety Corp. (HARMS)
Request that the FDA
Issue a Letter to Healthcare Providers,
an It Has Come to Our Attention Letter, and a
Safety Communication Letter Confirming that
Data from Regulations.gov