Definition: A Hypodermic Needle Is Intended To Inject Medication And Aspirate Fluid, Below The Surface Of The Skin. Designed To Be Used With Ultrasound For Better Visualization Of Needle During Use.
| Device Type ID | 2760 |
| Device Name | Non-stainless Steel Needle |
| Physical State | A Non-stainless Steel Hypodermic Needle Is A Single Lumen Needle That Is Composed Of A Material That Is Not Recognized As “stainless Steel” As Specified In ISO 9626: 2016. This Is Rigid Hollow Tubing May Be Straight And With An Echogenic Tip That Is |
| Technical Method | A Non-stainless Steel Hypodermic Needle Is A Single Lumen Needle That Is Composed Of A Material That Is Not Recognized As “stainless Steel” As Specified In ISO 9626: 2016. The Needle Hub Is Clear For Better Visualization Of Medication For Injection A |
| Target Area | Various Locations Of The Body For General Purpose Use For Injection Of Medication And Aspiration Of Fluid Where The Needle Gauge And Length Are Appropriate Based On Anatomy And Clinical Need. |
| Regulation Description | Hypodermic Single Lumen Needle. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PVZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2760 |
| Device | Non-stainless Steel Needle |
| Product Code | PVZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hypodermic Single Lumen Needle. |
| CFR Regulation Number | 880.5570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |