| Device Type ID | 5708 |
| Device Name | Kit, Surgical Instrument, Disposable |
| 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 | KDD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5708 |
| Device | Kit, Surgical Instrument, Disposable |
| Product Code | KDD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Delivered As Unsterile Product | 27 |
Material Integrity Problem | 8 |
Appropriate Term/Code Not Available | 6 |
Failure To Adhere Or Bond | 5 |
Device Operates Differently Than Expected | 5 |
Leak / Splash | 5 |
Device Damaged By Another Device | 5 |
Mechanical Problem | 5 |
Break | 4 |
Fluid Leak | 4 |
Device Contaminated During Manufacture Or Shipping | 4 |
Physical Property Issue | 4 |
Electrical /Electronic Property Problem | 3 |
Product Quality Problem | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Arcing | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Material Perforation | 2 |
Detachment Of Device Or Device Component | 2 |
Device Packaging Compromised | 2 |
Material Fragmentation | 2 |
Hole In Material | 2 |
Air Leak | 2 |
Fracture | 2 |
Material Frayed | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Degraded | 2 |
Unintended Ejection | 1 |
Device Difficult To Setup Or Prepare | 1 |
Strikethrough | 1 |
Activation, Positioning Or Separation Problem | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
Positioning Failure | 1 |
Unsealed Device Packaging | 1 |
Material Separation | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
Mechanical Jam | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Deformation | 1 |
Ejection Problem | 1 |
Defective Device | 1 |
Difficult To Position | 1 |
Material Distortion | 1 |
Flaked | 1 |
Difficult To Insert | 1 |
Dull, Blunt | 1 |
| Total Device Problems | 140 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | May-30-2018 |
| 2 | Arrow International Inc | II | Apr-03-2018 |
| 3 | Bioseal Corporation | II | Nov-09-2017 |
| 4 | Stryker Corporation | II | Mar-02-2018 |
| 5 | Utah Medical Products, Inc | II | Nov-06-2015 |
| 6 | Windstone Medical Packaging, Inc. | II | Dec-04-2015 |