IWA — Source, Wire, Iridium, Radioactive Class II
FDA Device Classification
Classification Details
- Product Code
- IWA
- Device Class
- Class II
- Regulation Number
- 892.5730
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K915253 | omnitron intl | IR-192 IMPLANT, MODIFICATION | February 27, 1992 |
| K894409 | amersham | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD | September 29, 1989 |
| K874895 | rads s.l | IR-192 IMPLANT | February 25, 1988 |
| K850382 | radiation safety and nuclear products | IRIDIUM SEEDS | August 15, 1985 |
| K844248 | rads s.l | IR-192 IMPLANT | April 10, 1985 |
| K850726 | syncor intl | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | March 26, 1985 |
| K850163 | syncor intl | IRIDIUM 192 WIRES | March 26, 1985 |
| K771878 | cis radiopharmaceuticals | IRIDIUM 192 WIRES & PINS | October 27, 1977 |