FDA product code IWG: Seed, Isotope, Gold, Titanium, Platinum
IWG is the FDA product code for seed, isotope, gold, titanium, platinum. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel. FDA has cleared 3 510(k) submissions under IWG, from 3 different applicants. The average 510(k) review took 24 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Seed, Isotope, Gold, Titanium, Platinum |
| Device class | Class II |
| Regulation | 21 CFR 892.5730 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every IWG clearance
Top IWG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medi-Physics, Inc., Dba GE Healthcare | 1 | 2008-05-05 |
| International Isotopes, Inc. | 1 | 1998-07-31 |
| Radiation Safety & Nuclear Products, Inc. | 1 | 1983-12-27 |
Most recent IWG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081066 | Medi-Physics, Inc., Dba GE Healthcare | BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 | 2008-05-05 | 20 |
| K982421 | International Isotopes, Inc. | IMAGYN 125 I SEED, MODEL IS 125 | 1998-07-31 | 18 |
| K834027 | Radiation Safety & Nuclear Products, Inc. | GOLD SEADS | 1983-12-27 | 35 |
Recalls for IWG devices
openFDA lists no recalls for product code IWG.
Frequently asked questions
What is FDA product code IWG?
IWG is the FDA product code for seed, isotope, gold, titanium, platinum. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel.
What device class is IWG?
Class II, regulation 21 CFR 892.5730. Typical premarket route: 510(k).
How long does a 510(k) take for product code IWG?
Across 3 cleared submissions the average was 24 days from receipt to decision (median 20).
Which companies have the most IWG clearances?
Medi-Physics, Inc., Dba GE Healthcare (1); International Isotopes, Inc. (1); Radiation Safety & Nuclear Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWG
- Run a recall and safety report across every IWG manufacturer
- Watch product code IWG 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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