da Vinci E-200 Electrosurgical Generator— 510(k) K223039

Name: FDA 510(k) clearance K223039
Creator: U.S. Food and Drug Administration
Published: 2022-11-28

Substantially Equivalent

Intuitive Surgical

FDA 510(k) clearance K223039 for da Vinci E-200 Electrosurgical Generator, Substantially Equivalent on 2022-11-28. Applicant: Intuitive Surgical. Device class: 2.

Clearance details

Applicant: Intuitive Surgical
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2022-09-29
Decision date: 2022-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Intuitive Surgical

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K260695 — da Vinci Firefly Imaging System2026-05-22
K241635 — da Vinci E-200 Electrosurgical Generator2024-08-05
K241621 — Da Vinci Monopolar and Bipolar Adapters (378896)2024-08-02
K240723 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)2024-05-24
K231212 — da Vinci E-200 Electrosurgical Generator2023-06-21

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.