Non-Stainless Steel Needle
The Non-Stainless Steel Needle is a general hospital device consisting of a hypodermic needle made from materials other than stainless steel, intended to inject medication and aspirate fluid below the skin surface, and specifically designed for use with ultrasound guidance to improve needle visualization during procedures. It is classified as FDA Class II under regulation 21 CFR 880.5570, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PVZ, falls under the General Hospital medical specialty, and is eligible for third-party review. It is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- PVZ
- Device Class
- FDA class 2
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K163437 | hypodermic Pinpoint GT Needle | Jun 23, 2017 | Substantially Equivalent | C. R. Bard, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.