FDA.report

510(k) K241635

Device
da Vinci E-200 Electrosurgical Generator
Applicant
Intuitive Surgical
510(k) number
K241635
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-05
Date received
2024-06-06
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Medha Sateesh Bharadwaj
Address
1266 Kifer Rd. Sunnyvale CA US 94086 94086

FDA Registration Numbers

Source Documents

510(k) summary PDF

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