PVZ — Non-Stainless Steel Needle Class II
FDA product code PVZ covers "Non-Stainless Steel Needle", a Class II medical device regulated under 21 CFR 880.5570. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PVZ
- Device Class
- Class II
- Regulation Number
- 880.5570
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163437 | c.r. bard | hypodermic Pinpoint GT Needle | June 23, 2017 |