Product code OCL— General, Plastic Surgery
ATRICURE BIPOLAR SYSTEM
- Classification name
- Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 54
- First cleared
- Most recent
FDA classification definition
“Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue”
Market context for product code OCL
FDA has cleared devices under product code OCL between 1997 and 2025, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
Top applicants under product code OCL
Adverse events under product code OCL
product code OCL- Death
- 34
- Injury
- 256
- Total
- 290
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OCL
- K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
- K234151 — Isolator Synergy EnCapture Ablation System (EMH)
- K221358 — Isolator® Linear Pen (MLP1) +4 more
- K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
- K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
- K211311 — AtriCure Isolator® Synergy Surgical Ablation System
- K200514 — Cardioblate Gemini-s Surgical Ablation Device
- K193162 — EPi-Sense Guided Coagulation System with VisiTrax
- K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
- K191526 — Cardioblate CryoFlex Surgical Ablation System
- K190587 — Coolrail Linear Pen
- K190623 — Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
- K190151 — COBRA Fusion Ablation System
- K182610 — Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
- K183065 — Coolrail Linear Pen
- K163408 — Isolator Multifunctional Linear Pen
- K142084 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
- K130521 — ISOLATOR LINEAR PEN
- K123733 — CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
- K120857 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
- K121878 — CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
- K122611 — COOLRAIL LINEAR PEN MODEL MCRI
- K121767 — CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
- K121451 — CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
- K113475 — ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
- K110913 — ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
- K110117 — ATRICURE BIPOLAR SYSTEM
- K101174 — ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
- K100501 — MULTIFUNCTIONAL LINEAR PEN
- K090721 — CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
- K090202 — NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
- K082203 — NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021; CSK-022; CSK-023; CSK-025
- K082279 — EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
- K080292 — EPICOR ABLATION SYSTEM
- K080509 — CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
- K073605 — ATRICURE COOLRAIL LINEAR PEN
- K071819 — NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
- K043579 — ATRICURE BIPOLAR SYSTEM
- K070288 — CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
- K063012 — NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
- K062140 — SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1
- K061593 — ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
- K060715 — MODIFICATION TO: CARDIMA ABLATION SYSTEM
- K053436 — SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
- K050459 — ATRICURE ISOLATOR TRANSPOLAR PEN
- K041890 — CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
- K040690 — SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
- K022008 — CARDIMA ABLATION SYSTEM
- K021010 — MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
- K013392 — CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
- K011988 — SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
- K011040 — CRYOCARE CARDIAC SURGICAL SYSTEM
- K974320 — CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
- K970496 — HEARTPORT MAZE SYSTEM: CRYOPROBE SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.