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Nonrulemaking
FDA
Open for Comments
FDA-2026-P-1819
Request that the FDA Immediately Rescind or Amend 510(k) Clearance K252675 (December 15, 2025) for the da Vinci SP Surgical System by Removing Nipple Sparing Mastectomy (NSM) Procedures from Indications for Use Until Long-Term Oncologic Safety and Non-Inferiority Data Are Established, Restore the 2019 and 2021 Safety Communications, Issue Updated Guidance, and Conduct
Documents
5
Comments
0
Description
OPEN
Key Dates
Comment Period OpensFeb 19, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Keywords
CDRH
Citizen Petition
Harmed Americans for Reform
in Medical-Device Safety Corp.
Rescind or amend 510(k) clearance K252675
to immediately remove
nipple sparing mastectomy (NSM)
procedures from the Indications for
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