FDA product code PVZ: Non-Stainless Steel Needle
PVZ is the FDA product code for non-stainless steel needle. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under PVZ. The average 510(k) review took 198 days (median 198). FDA has posted 1 recall for PVZ devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Non-Stainless Steel Needle |
| Device class | Class II |
| Regulation | 21 CFR 880.5570 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PVZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 198 |
Compare with all 510(k) review times · Search every PVZ clearance
Top PVZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 1 | 2017-06-23 |
Most recent PVZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163437 | C.R. Bard, Inc. | hypodermic Pinpoint GT Needle | 2017-06-23 | 198 |
Recalls for PVZ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-07-10.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code PVZ?
PVZ is the FDA product code for non-stainless steel needle. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is PVZ?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code PVZ?
Across 1 cleared submissions the average was 198 days from receipt to decision (median 198).
Which companies have the most PVZ clearances?
C.R. Bard, Inc. (1).
Have PVZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code PVZ
- Run a recall and safety report across every PVZ manufacturer
- Watch product code PVZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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