Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

Device Code: 999

Product Code(s): OCL

Definition: Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

Device Classification Information

Device Type ID999
Device NameSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Physical StateThe Device Tip Delivers Energy To Provide Cutting, Coagulation, And/or Ablation Of The Contacted Tissue
Technical MethodThe Device Energy Source Used To Provide Cutting, Coagulation And/or Ablation May Be Radio Frequency (RF), Cryogenic, Laser Or Ultrasound
Target AreaCardiac Tissue.
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Electrophysiology Devices Branch (CEDB)
Submission Type510(k)
CFR Regulation Number878.4400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOCL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID999
DeviceSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Product CodeOCL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
CFR Regulation Number878.4400 [🔎]
Premarket Reviews
ManufacturerDecision
ATRICURE, INC.
 
SUBSTANTIALLY EQUIVALENT
4
MEDTRONIC
 
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
1
NCONTACT SURGICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Adverse Event Without Identified Device Or Use Problem
151
Detachment Of Device Component
42
Failure To Adhere Or Bond
14
Device Dislodged Or Dislocated
10
Detachment Of Device Or Device Component
7
Device Handling Problem
4
Material Fragmentation
3
Use Of Device Problem
3
Material Integrity Problem
3
Fracture
2
Migration Or Expulsion Of Device
2
Loss Of Or Failure To Bond
2
Break
2
Mechanical Problem
1
Insufficient Information
1
Positioning Problem
1
Failure To Power Up
1
Material Separation
1
Inadequate Or Insufficient Training
1
Human Factors Issue
1
Device Operates Differently Than Expected
1
Energy Output To Patient Tissue Incorrect
1
Improper Or Incorrect Procedure Or Method
1
Total Device Problems 255
Recalls
Manufacturer Recall Class Date Posted
1
AtriCure, Inc.
II Feb-14-2019
2
AtriCure, Inc.
II Nov-22-2016
TPLC Last Update: 2019-03-09 16:18:15

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