Panels › General, Plastic Surgery › Product code OCL · Class 2
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Regulation 878.4400
0510(k)s in 12 months (54 all time)
0recalls in 12 months (17 all time)
17recalls that name a 510(k)
Top companies in OCL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2022 | Medtronic Perfusion Systems 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 dev Open, Classified |
OCL | K121767 K200514 |
| Sep 27, 2021 | Medtronic Perfusion Systems Cardioblate CryoFlex Surgical Ablation Console Open, Classified |
OCL | K123733 |
| Oct 12, 2020 | MEDTRONIC ATS MEDICAL, INC. 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 S Terminated |
OCL | K123733 |
| Oct 12, 2020 | MEDTRONIC ATS MEDICAL, INC. 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 Sys Terminated |
OCL | K123733 |
| Oct 12, 2020 | MEDTRONIC ATS MEDICAL, INC. 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 Sy Terminated |
OCL | K123733 |
| Oct 12, 2020 | MEDTRONIC ATS MEDICAL, INC. 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 Surgi Terminated |
OCL | K123733 |
| May 29, 2019 | AtriCure, Inc. EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation Terminated |
OCL | K142084 |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI Terminated |
OCL | K113475 |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S Terminated |
OCL | K113475 |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 Terminated |
OCL | K113475 |
| Jan 22, 2019 | AtriCure, Inc. COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 Terminated |
OCL | K113475 |
| Sep 22, 2016 | AtriCure, Inc. COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003.
Intended to ablate c Terminated |
OCL | K113475 |
| Mar 6, 2013 | Atricure Inc Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Uni Terminated |
OCL | K050459 K061593 |
| Sep 27, 2010 | Cardima Inc Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA Terminated |
OCL | K022008 K060715 |
| Sep 27, 2010 | Cardima Inc Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA Terminated |
OCL | K022008 K060715 |
| Jun 7, 2010 | St. Jude Medical Atrial Fibrillation Division Inc St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablatio Terminated |
OCL | K080292 |
| Jan 30, 2009 | St. Jude Medical Inc Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA
Disposable connecting cable, ac Terminated |
OCL | K080292 |
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