Atlas FDA

ATRICURE ISOLATOR TRANSPOLAR PEN

FDA 510(k) clearance K050459 · decided 2005-06-13

Clearance details

K-number
K050459
Device name
ATRICURE ISOLATOR TRANSPOLAR PEN
Applicant
AtriCure, Inc.
Decision
Substantially Equivalent
Date received
2005-02-23
Decision date
2005-06-13
Days to decision
110 days
Clearance type
Traditional
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
West Chester, OH, US
Third-party review
Yes
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (K252056)AtriCure, Inc.2025-07-24
Isolator Synergy EnCapture Ablation System (EMH) (K234151)AtriCure, Inc.2024-08-27
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) (K221358)AtriCure, Inc.2022-12-30
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device (K223508)Medtronic, Inc.2022-12-22
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (K210477)AtriCure, Inc.2021-07-26
AtriCure Isolator® Synergy™ Surgical Ablation System (K211311)AtriCure, Inc.2021-05-28
Cardioblate Gemini-s Surgical Ablation Device (K200514)Medtronic2020-06-03
EPi-Sense Guided Coagulation System with VisiTrax (K193162)AtriCure, Inc.2019-12-13
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (K192125)AtriCure, Inc.2019-11-04
Cardioblate CryoFlex Surgical Ablation System (K191526)Medtronic, Inc.2019-10-01
Coolrail Linear Pen (K190587)AtriCure, Inc.2019-07-24
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device (K190623)Medtronic2019-05-30

Recalls involving this device

RecordFirmDate
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues recall (Z-0912-2013)Atricure Inc2013-03-06

PMA approvals by this applicant

RecordFirmDate
EPi-Sense ST Coagulation System (P200002/S013)AtriCure, Inc.2025-11-14
EPi-Sense Guided Coagulation System (P200002/S012)AtriCure, Inc.2025-10-07
Synergy Ablation System (P100046/S019)AtriCure, Inc.2025-06-17
EPi-Sense Guided Coagulation System (P200002/S011)AtriCure, Inc.2025-06-17
EPi-Sense and EPi-Sense ST Guided Coagulation System (P200002/S010)AtriCure, Inc.2025-03-03
Cannula with Guide (P200002/S009)AtriCure, Inc.2024-08-28
Synergy Ablation System (P100046/S018)AtriCure, Inc.2024-03-15
EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System (P200002/S008)AtriCure, Inc.2023-12-11