| Device Type ID | 5626 |
| Device Name | Guide, Needle, Surgical |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GDF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5626 |
| Device | Guide, Needle, Surgical |
| Product Code | GDF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 8 |
Activation Failure Including Expansion Failures | 4 |
Signal Artifact | 2 |
Device Operates Differently Than Expected | 2 |
Insufficient Information | 2 |
Device Markings / Labelling Problem | 2 |
Difficult To Advance | 1 |
Component Falling | 1 |
Device Or Device Fragments Location Unknown | 1 |
Detachment Of Device Or Device Component | 1 |
Plug | 1 |
Detachment Of Device Component | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Positioning Failure | 1 |
Unsealed Device Packaging | 1 |
Suture | 1 |
Difficult To Remove | 1 |
Tip | 1 |
| Total Device Problems | 32 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bard Peripheral Vascular Inc | II | May-02-2017 |
| 2 | Bard Peripheral Vascular Inc | II | Sep-16-2014 |
| 3 | Hologic, Inc | II | Sep-08-2016 |
| 4 | Stryker Instruments Div. Of Stryker Corporation | II | Mar-03-2016 |