Definition: The Ultrasonic Scalpel Is Intended For Incision And Excision Of Soft Tissues. This Device Is Indicated For Reuse/reprocessing.
| Device Type ID | 5949 |
| Device Name | Scalpel, Ultrasonic, Reprocessed |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | NLQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5949 |
| Device | Scalpel, Ultrasonic, Reprocessed |
| Product Code | NLQ |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STERILMED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STERILMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 21 |
Energy Output To Patient Tissue Incorrect | 16 |
Device Displays Incorrect Message | 16 |
Detachment Of Device Component | 12 |
Detachment Of Device Or Device Component | 7 |
Thermal Decomposition Of Device | 6 |
Material Fragmentation | 6 |
Melted | 5 |
Device Inoperable | 4 |
Material Separation | 4 |
Adhesive | 2 |
Insufficient Information | 2 |
Noise, Audible | 2 |
Split | 2 |
Difficult To Open Or Close | 2 |
Failure To Auto Stop | 2 |
Pad | 2 |
Appropriate Term/Code Not Available | 1 |
Activation Problem | 1 |
Device Difficult To Setup Or Prepare | 1 |
Smoking | 1 |
Failure To Cut | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Device Remains Activated | 1 |
Energy Output Problem | 1 |
Fracture | 1 |
Device Operational Issue | 1 |
Charred | 1 |
Component Falling | 1 |
Peeled / Delaminated | 1 |
Environmental Particulates | 1 |
| Total Device Problems | 126 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Sustainability Solutions | II | Jul-18-2018 |