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Nonrulemaking
FDA
Open for Comments
FDA-2026-P-2212
Requests that the FDA Investigate Mayo Clinic Promotion and Use of Robotic Nipple-Sparing Mastectomy Using the da Vinci SP Surgical System Outside the Ongoing Investigational Device Exemption; Investigate Intuitive Surgicals Role in this Promotion; Reevaluate Clearance of da Vinci SP Surgical System for Robotic Nipple-Sparing Mastectomy (K252675); Require Post-Market Surveillance/Labeling Changes
Documents
3
Comments
0
Description
Open
Key Dates
Comment Period OpensMar 3, 2026
Documents
Keywords
CDRH
Citizen Petition
Harmed Americans for Reform
in Medical-Device Safety Corp. (HARMS)
Requests that the FDA Investigate Mayo Clinic
Promotion and Use of Robotic Nipple-Sparing
Mastectomy Using the da Vinci SP Surgical System
Outside the Ongoing Investigational
Data from Regulations.gov