K201279 is an FDA 510(k) clearance for the ASSISTO Universal Applicator Clamping Device. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Geomed Medizin-Technik GmbH & Co. KG (Tuttlingen, DE). The FDA issued a Cleared decision on July 10, 2020, 58 days after receiving the submission on May 13, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K201279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2020 |
| Decision Date | July 10, 2020 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ - System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |