Product code OCL— General, Plastic Surgery
ATRICURE BIPOLAR SYSTEM
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 54
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); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
- 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.