Iridium 192 Wires
FDA 510(k) K850163 · Syncor Intl. Corp.
510(k) numberK850163
Submission
- Device name
- Iridium 192 Wires
- Applicant
- Syncor Intl. Corp.
Sylmar, CA, US - Received
- January 16, 1985
- Decision date
- March 26, 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 |
| 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 |
| K771878 | Iridium 192 Wires & PinsIWA · Traditional | Cis Radiopharmaceuticals, Inc. | 10/27/1977SE |
More from Cis Radiopharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945825 | Secure Safety InsertFMI · Traditional | 04/10/1995SE |
| K851828 | Irradiator for Biological Materials IBL-437-CMOT · Traditional | 09/19/1985SE |
| K852023 | Cesium 137 Source, CSM-4, CSM-11, CSM-41KXK · Traditional | 08/21/1985SE |
| K850433 | Cesium 137 Endometrial SourceKXK · Traditional | 08/21/1985SE |
| K852665 | Syncor Trich Direct Immunofluorescence AssayJWZ · Traditional | 08/13/1985SE |
| K851033 | Syncortech Chlamydia Direct Speciman KitLJP · Traditional | 06/21/1985SE |
| K844735 | Pth-RiaCEW · Traditional | 04/29/1985SE |
| K850726 | Wire Cutters, Brachytherapy-Table Top & Hand HeldIWA · Traditional | 03/26/1985SE |
| K850434 | CS137 Sealed SourcesKXK · Traditional | 03/26/1985SE |
| K850208 | Flood Sources & Dose Calibrators W/Various NuclidsIXD · Traditional | 03/26/1985SE |
Questions and answers
When was Iridium 192 Wires cleared by the FDA?
Iridium 192 Wires (K850163) received a 510(k) decision of Substantially Equivalent on March 26, 1985, 69 days after the submission was received.
What is the product code of K850163?
The FDA product code is IWA – Source, Wire, Iridium, Radioactive, a Class II (moderate risk) device regulated under 21 CFR 892.5730.