CS137 Sealed Sources
FDA 510(k) K850434 · Syncor Intl. Corp.
510(k) numberK850434
Submission
- Device name
- CS137 Sealed Sources
- Applicant
- Syncor Intl. Corp.
Sylmar, CA, US - Received
- February 4, 1985
- Decision date
- March 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K221539 | GammaTileKXK · Traditional | Gt Medical Technologies | 11/09/2022SE |
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More from Isoray Medical, 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 |
| K850208 | Flood Sources & Dose Calibrators W/Various NuclidsIXD · Traditional | 03/26/1985SE |
| K850163 | Iridium 192 WiresIWA · Traditional | 03/26/1985SE |
Questions and answers
When was CS137 Sealed Sources cleared by the FDA?
CS137 Sealed Sources (K850434) received a 510(k) decision of Substantially Equivalent on March 26, 1985, 50 days after the submission was received.
What is the product code of K850434?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.