CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM— 510(k) K123733

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

2012-12-05

Decision date

2013-04-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mounds View, MN, US

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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 →

• Z-0273-2022 — Cardioblate CryoFlex Surgical Ablation ConsoleClass II·Ongoing·Medtronic Perfusion Systems·20210927
• Z-0493-2021 — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.Class II·Terminated·MEDTRONIC ATS MEDICAL, INC.·20201012
• Z-0494-2021 — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.Class II·Terminated·MEDTRONIC ATS MEDICAL, INC.·20201012
• Z-0495-2021 — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.Class II·Terminated·MEDTRONIC ATS MEDICAL, INC.·20201012
• Z-0496-2021 — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.Class II·Terminated·MEDTRONIC ATS MEDICAL, INC.·20201012

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123733.