Polaris Bipolar Electrosurgical Generator (29-1000) +3 more— 510(k) K231872

Name: FDA 510(k) clearance K231872
Creator: U.S. Food and Drug Administration
Published: 2023-08-25

Substantially Equivalent

Kirwan Surgical Products, LLC

FDA 510(k) clearance K231872 for Polaris Bipolar Electrosurgical Generator (29-1000) +3 more, Substantially Equivalent on 2023-08-25. Applicant: Kirwan Surgical Products, LLC. Device class: 2.

Clearance details

Device name as filed: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
Applicant: Kirwan Surgical Products, LLC
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2023-06-26
Decision date: 2023-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marshfield, MA, US

Download summary PDF View on FDA.gov ↗

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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.