INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)— 510(k) K100641

Substantially Equivalent

Relievant Medsystems

FDA 510(k) clearance K100641 for INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET), Substantially Equivalent on 2010-03-30. Applicant: Relievant Medsystems.

Clearance details

Applicant: Relievant Medsystems
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2010-03-05
Decision date: 2010-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

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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.