| Device Type ID | 5652 |
| Device Name | Blade, Scalpel |
| Regulation Description | Manual Surgical Instrument For General Use. |
| 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) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GES |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5652 |
| Device | Blade, Scalpel |
| Product Code | GES |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 22 |
Mechanical Problem | 12 |
Dull, Blunt | 8 |
Material Integrity Problem | 8 |
Failure To Cut | 7 |
Device Operates Differently Than Expected | 6 |
Fracture | 4 |
Tear, Rip Or Hole In Device Packaging | 3 |
Microscope | 3 |
Corroded | 3 |
Product Quality Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Defective Device | 2 |
Out-Of-Box Failure | 2 |
System | 2 |
Device Handling Problem | 2 |
Incomplete Or Missing Packaging | 1 |
Material Fragmentation | 1 |
Detachment Of Device Component | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Deformation | 1 |
Detachment Of Device Or Device Component | 1 |
Inadequate User Interface | 1 |
Insufficient Information | 1 |
Loose Or Intermittent Connection | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Delivered As Unsterile Product | 1 |
Contamination / Decontamination Problem | 1 |
Connection Problem | 1 |
Tip | 1 |
Appropriate Term/Code Not Available | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 108 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aspen Surgical Puerto Rico Corp. | II | Sep-08-2016 |