Iridium Seeds
FDA 510(k) K850382 · Radiation Safety & Nuclear Products, Inc.
510(k) numberK850382
Submission
- Device name
- Iridium Seeds
- Applicant
- Radiation Safety & Nuclear Products, Inc.
Salt Lake City, UT, US - Received
- February 1, 1985
- Decision date
- August 15, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IWA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K915253 | IR-192 Implant, ModificationIWA · Traditional | Omnitron Intl., Inc. | 02/27/1992SE |
| K894409 | CESIUM-137 Microseed Source Train Assembly/ShieldIWA · Traditional | Amersham Corp. | 09/29/1989SE |
| K874895 | IR-192 ImplantIWA · Traditional | Rads S.L., Inc. | 02/25/1988SE |
| K844248 | IR-192 ImplantIWA · Traditional | Rads S.L., Inc. | 04/10/1985SE |
| K850726 | Wire Cutters, Brachytherapy-Table Top & Hand HeldIWA · Traditional | Syncor Intl. Corp. | 03/26/1985SE |
| K850163 | Iridium 192 WiresIWA · Traditional | Syncor Intl. Corp. | 03/26/1985SE |
| K771878 | Iridium 192 Wires & PinsIWA · Traditional | Cis Radiopharmaceuticals, Inc. | 10/27/1977SE |
More from Cis Radiopharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834027 | Gold SeadsIWG · Traditional | 12/27/1983SE |
Questions and answers
When was Iridium Seeds cleared by the FDA?
Iridium Seeds (K850382) received a 510(k) decision of Substantially Equivalent on August 15, 1985, 195 days after the submission was received.
What is the product code of K850382?
The FDA product code is IWA – Source, Wire, Iridium, Radioactive, a Class II (moderate risk) device regulated under 21 CFR 892.5730.