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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

5 rows where docket_id = "FDA-2026-P-5453" sorted by posted_date descending

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Suggested facets: subtype, open_for_comment, posted_date (date), comment_start_date (date), last_modified (date)

document_type 2

  • Supporting & Related Material 3
  • Other 2

posted_year 1

  • 2026 5

agency_id 1

  • FDA 5
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2026-P-5453-0004 FDA 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 FDA-2026-P-5453 Attachment 2 - de la Plaza Llamas et al. - Laparoscopic Removal of a Displaced Vertical Gastric Clip Causing Gastric Outlet Obstruction Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:05:03Z   0 0 09000064b92d58f6
FDA-2026-P-5453-0003 FDA 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 FDA-2026-P-5453 Attachment 1 - Bonaldi et al. - 2024 - BariClip Outcomes and Complications from a Single-Center Experience Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:04:57Z   0 0 09000064b92d58f5
FDA-2026-P-5453-0002 FDA 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 FDA-2026-P-5453 Acknowledgement Letter from FDA DMB to Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS) Other Acknowledgement Letter/Receipt 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:04:37Z   0 0 09000064b92d5159
FDA-2026-P-5453-0005 FDA 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 FDA-2026-P-5453 Attachment 3 - Jacobs et al. - 2017 - A Vertically Placed Clip for Weight Loss: a 39-Month Pilot Study Supporting & Related Material Background Material 2026-05-13T04:00:00Z 2026 5     2026-05-13T23:05:09Z   0 0 09000064b92d5d02
FDA-2026-P-5453-0001 FDA 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 FDA-2026-P-5453 Citizen Petition from Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS) Other Citizen Petition 2026-05-13T04:00:00Z 2026 5 2026-05-13T04:00:00Z   2026-05-13T23:00:37Z   1 0 09000064b92d5158

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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