IWA
8 FDA 510(k) clearances · Product code
86 daysmedian time to decision
195 days90th percentile
8clearances measured
FDA profile
- Official device name
- Source, Wire, Iridium, Radioactive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5730
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 2005: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IR-192 IMPLANT, MODIFICATION (K915253) | Omnitron Intl., Inc. | 1992-02-27 |
| CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD (K894409) | Amersham Corp. | 1989-09-29 |
| IR-192 IMPLANT (K874895) | Rads S.L., Inc. | 1988-02-25 |
| IRIDIUM SEEDS (K850382) | Radiation Safety & Nuclear Products, Inc. | 1985-08-15 |
| IR-192 IMPLANT (K844248) | Rads S.L., Inc. | 1985-04-10 |
| WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (K850726) | Syncor Intl. Corp. | 1985-03-26 |
| IRIDIUM 192 WIRES (K850163) | Syncor Intl. Corp. | 1985-03-26 |
| IRIDIUM 192 WIRES & PINS (K771878) | Cis Radiopharmaceuticals, Inc. | 1977-10-27 |
Track IWA automatically
Every clearance here is in the API, with alerts when new ones post.