| Device Type ID | 5783 |
| Device Name | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NUJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5783 |
| Device | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Product Code | NUJ |
| 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 | |
RENOVO, INC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STERILMED | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STERILMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Difficult To Open Or Close | 23 |
Device Operates Differently Than Expected | 13 |
Failure To Cut | 12 |
Energy Output To Patient Tissue Incorrect | 9 |
Break | 6 |
Sticking | 4 |
Self-Activation Or Keying | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Electrical /Electronic Property Problem | 2 |
Failure To Auto Stop | 2 |
Failure To Fire | 2 |
Peeled / Delaminated | 2 |
Charred | 2 |
Device Slipped | 2 |
Failure To Align | 1 |
Detachment Of Device Or Device Component | 1 |
Output Problem | 1 |
Temperature Problem | 1 |
Insufficient Information | 1 |
Mechanical Problem | 1 |
Detachment Of Device Component | 1 |
Material Deformation | 1 |
Physical Resistance / Sticking | 1 |
Material Fragmentation | 1 |
Failure To Power Up | 1 |
Mechanical Jam | 1 |
Protective Measures Problem | 1 |
Patient Device Interaction Problem | 1 |
Material Integrity Problem | 1 |
Device Inoperable | 1 |
Bent | 1 |
Device Operational Issue | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Device Remains Activated | 1 |
Intermittent Continuity | 1 |
| Total Device Problems | 107 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | STERILMED, INC. | II | May-31-2016 |