DEN200041 is an FDA 510(k) submission for the Comfort Marker 2.0.. This device is classified as a Radiation Therapy Marking Device (Class II - Special Controls, product code QRN).
Submitted by Medical Precision BV (Zwolle, NL). The FDA issued a Not Cleared (DENG) decision on December 10, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5785. A Radiation Therapy Marking Device Is A Powered Device That Transdermally Delivers A Permanent Or Temporary Colorant To The Skin For The Purpose Of Placing Marks To Guide Radiation Therapy. This Classification Does Not Include Devices With Reusable Or Reprocessed Needles Or Devices Intended For Diagnostic, Therapeutic, Or Aesthetic Use Or To Deliver Other Products For These Uses..
| 510(k) Number | DEN200041 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 22, 2020 |
| Decision Date | December 10, 2021 |
| Days to Decision | 536 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | QRN - Radiation Therapy Marking Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5785 |
| Definition | A Radiation Therapy Marking Device Is A Powered Device That Transdermally Delivers A Permanent Or Temporary Colorant To The Skin For The Purpose Of Placing Marks To Guide Radiation Therapy. This Classification Does Not Include Devices With Reusable Or Reprocessed Needles Or Devices Intended For Diagnostic, Therapeutic, Or Aesthetic Use Or To Deliver Other Products For These Uses. |