FDA product code IWW: Shield, Vial
IWW is the FDA product code for shield, vial. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IWW. The average 510(k) review took 51 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Shield, Vial |
| Device class | Class I |
| Regulation | 21 CFR 892.6500 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IWW clearance
Top IWW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Victoreen, Inc. | 1 | 1993-11-12 |
Most recent IWW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934548 | Victoreen, Inc. | ALL-VUE & GAMMA-VUE VIAL SHIELDS | 1993-11-12 | 51 |
Recalls for IWW devices
openFDA lists no recalls for product code IWW.
Frequently asked questions
What is FDA product code IWW?
IWW is the FDA product code for shield, vial. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is IWW?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWW?
Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most IWW clearances?
Victoreen, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWW
- Run a recall and safety report across every IWW manufacturer
- Watch product code IWW 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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