FDA product code IWA: Source, Wire, Iridium, Radioactive
IWA is the FDA product code for source, wire, iridium, radioactive. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel. FDA has cleared 8 510(k) submissions under IWA, from 6 different applicants. The average 510(k) review took 92 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Source, Wire, Iridium, Radioactive |
| Device class | Class II |
| Regulation | 21 CFR 892.5730 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IWA clearance
Top IWA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rads S.L., Inc. | 2 | 1988-02-25 |
| Syncor Intl. Corp. | 2 | 1985-03-26 |
| Omnitron Intl., Inc. | 1 | 1992-02-27 |
| Amersham Corp. | 1 | 1989-09-29 |
| Radiation Safety & Nuclear Products, Inc. | 1 | 1985-08-15 |
1 more applicants have IWA clearances. See the full list in Caduvo.
Most recent IWA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K915253 | Omnitron Intl., Inc. | IR-192 IMPLANT, MODIFICATION | 1992-02-27 | 101 |
| K894409 | Amersham Corp. | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD | 1989-09-29 | 74 |
| K874895 | Rads S.L., Inc. | IR-192 IMPLANT | 1988-02-25 | 86 |
| K850382 | Radiation Safety & Nuclear Products, Inc. | IRIDIUM SEEDS | 1985-08-15 | 195 |
| K844248 | Rads S.L., Inc. | IR-192 IMPLANT | 1985-04-10 | 159 |
Recalls for IWA devices
openFDA lists no recalls for product code IWA.
Frequently asked questions
What is FDA product code IWA?
IWA is the FDA product code for source, wire, iridium, radioactive. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel.
What device class is IWA?
Class II, regulation 21 CFR 892.5730. Typical premarket route: 510(k).
How long does a 510(k) take for product code IWA?
Across 8 cleared submissions the average was 92 days from receipt to decision (median 80).
Which companies have the most IWA clearances?
Rads S.L., Inc. (2); Syncor Intl. Corp. (2); Omnitron Intl., Inc. (1); Amersham Corp. (1); Radiation Safety & Nuclear Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWA
- Run a recall and safety report across every IWA manufacturer
- Watch product code IWA 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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