| Device Type ID | 744 |
| Device Name | Trocar |
| Regulation Description | Trocar. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.1390 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRC |
| 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 | 744 |
| Device | Trocar |
| Product Code | DRC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Trocar. |
| CFR Regulation Number | 870.1390 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OSCOR INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSCOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNAPTIC MEDICAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 123 |
Activation, Positioning Or Separation Problem | 18 |
Break | 17 |
Use Of Device Problem | 3 |
Bent | 3 |
Tear, Rip Or Hole In Device Packaging | 2 |
Appropriate Term/Code Not Available | 2 |
Detachment Of Device Component | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Material Separation | 2 |
Air Leak | 1 |
Material Fragmentation | 1 |
Physical Resistance / Sticking | 1 |
Leak / Splash | 1 |
Partial Blockage | 1 |
Defective Device | 1 |
Needle | 1 |
Difficult To Insert | 1 |
Kinked | 1 |
Loose Or Intermittent Connection | 1 |
Malposition Of Device | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Hemo Valve | 1 |
Device Difficult To Maintain | 1 |
Delivered As Unsterile Product | 1 |
Failure To Adhere Or Bond | 1 |
Expiration Date Error | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 193 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | I | Mar-13-2019 |
| 2 | CooperSurgical, Inc. | II | May-01-2018 |
| 3 | CooperSurgical, Inc. D.B.A. Lone Star Medical Products | II | Oct-29-2014 |
| 4 | Ethicon Endo-Surgery Inc | II | Jun-26-2015 |
| 5 | Instrumed International, Inc. | II | Dec-16-2014 |
| 6 | Merit Medical Systems, Inc. | II | Apr-12-2016 |