Definition: Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
| Device Type ID | 1001 |
| Device Name | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Physical State | The Device Tip Delivers Energy To Provide Cutting, Coagulation, And/or Ablation Of The Contacted Tissue |
| Technical Method | The Device Energy Source Used To Provide Cutting, Coagulation And/or Ablation May Be Radio Frequency (RF), Cryogenic, Laser Or Ultrasound |
| Target Area | Cardiac Tissue. |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Electrophysiology Devices Branch (CEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1001 |
| Device | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Product Code | OCL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
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 |