INCIRCLE BI-POLAR RF ABLATION SYSTEM— 510(k) K070711

Name: FDA 510(k) clearance K070711
Creator: U.S. Food and Drug Administration
Published: 2007-04-24

Substantially Equivalent

Rfa Medical, Inc.

FDA 510(k) clearance K070711 for INCIRCLE BI-POLAR RF ABLATION SYSTEM, Substantially Equivalent on 2007-04-24. Applicant: Rfa Medical, Inc.. Device class: 2.

Clearance details

Applicant: Rfa Medical, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2007-03-14
Decision date: 2007-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

view all

K254185 — Potenza Prime2026-09-11
K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

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.