| Device Type ID | 5583 |
| Device Name | Needle, Aspiration And Injection, 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 | GAA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5583 |
| Device | Needle, Aspiration And Injection, Disposable |
| Product Code | GAA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 50 |
Adverse Event Without Identified Device Or Use Problem | 18 |
Fracture | 14 |
Detachment Of Device Or Device Component | 6 |
Device Operates Differently Than Expected | 5 |
Signal Artifact | 4 |
Contamination / Decontamination Problem | 3 |
Material Fragmentation | 3 |
Detachment Of Device Component | 2 |
Leak / Splash | 2 |
Insufficient Information | 2 |
Migration Or Expulsion Of Device | 2 |
Difficult To Remove | 1 |
Contamination During Use | 1 |
Product Quality Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Solder Joint Fracture | 1 |
Suction Failure | 1 |
Tip | 1 |
Packaging Problem | 1 |
Defective Device | 1 |
Delivery System Failure | 1 |
Device Damaged Prior To Use | 1 |
Device Markings / Labelling Problem | 1 |
Difficult To Advance | 1 |
Failure To Obtain Sample | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Deformation | 1 |
Coil | 1 |
Partial Blockage | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 130 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cadence Inc. | II | Aug-10-2015 |