Iridium 192 Wires & Pins
FDA 510(k) K771878 · Cis Radiopharmaceuticals, Inc.
510(k) numberK771878
Submission
- Device name
- Iridium 192 Wires & Pins
- Applicant
- Cis Radiopharmaceuticals, Inc.
Mchenry, IL, US - Received
- October 4, 1977
- Decision date
- October 27, 1977
- 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 |
| K850382 | Iridium SeedsIWA · Traditional | Radiation Safety & Nuclear Products, Inc. | 08/15/1985SE |
| 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 |
More from Syncor Intl. Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K791860 | Ferritin Ria KitDBF · Traditional | 12/06/1979SE |
| K792063 | Follicle Stimulating Hormone (FSH) KitCGJ · Traditional | 11/20/1979SE |
| K791202 | Ria Kit for TrypsinJNO · Traditional | 11/05/1979SE |
| K792000 | Luteinizing Hormone (LH) RiaCEP · Traditional | 10/30/1979SE |
| K791051 | Progesterone Radioimmunoassay KitJLS · Traditional | 07/24/1979SE |
| K790003 | Ria Kit, ProlactinCFT · Traditional | 03/12/1979SE |
| K780982 | Kits, Ria, Myoglobin, Human, MeasurementDDR · Traditional | 06/22/1978SE |
| K760251 | Set, Oral AdministrationLEY · Traditional | 09/15/1976SE |
Questions and answers
When was Iridium 192 Wires & Pins cleared by the FDA?
Iridium 192 Wires & Pins (K771878) received a 510(k) decision of Substantially Equivalent on October 27, 1977, 23 days after the submission was received.
What is the product code of K771878?
The FDA product code is IWA – Source, Wire, Iridium, Radioactive, a Class II (moderate risk) device regulated under 21 CFR 892.5730.