CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE— 510(k) K121767

Name: FDA 510(k) clearance K121767
Creator: U.S. Food and Drug Administration
Published: 2012-07-13

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K121767 for CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, Substantially Equivalent on 2012-07-13. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code OCL
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2012-06-15
Decision date: 2012-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

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 →

Recalls naming K121767

K-number listed on FDA's recall record

Z-1131-2022 — Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.Class II·Ongoing·Medtronic Perfusion Systems·20220420

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121767.

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