BiomarC Fiducial Marker
FDA 510(k) K191797 · Carbon Medical Technologies
510(k) numberK191797
Submission
- Device name
- BiomarC Fiducial Marker
- Applicant
- Carbon Medical Technologies
St. Paul, MN, US - Received
- July 3, 2019
- Decision date
- July 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K172227 | Endoscopic Injection NeedleFBK · Special | 08/23/2017SE |
| K133148 | Biomarc Coaxial NeedleFBK · Traditional | 05/13/2014SE |
| K132064 | Biomarc Fiducial MarkerIYE · Traditional | 02/28/2014SE |
| K132708 | Biomarc Fiducial MarkerNEU · Traditional | 12/20/2013SE |
| K130678 | Biomarc Gold Fiducial MarkerIYE · Special | 04/12/2013SE |
| K110772 | Biomarc Fiducial MarkerIYE · Traditional | 04/28/2011SE |
| K100994 | Preloaded Tissue Marker DeviceNEU · Special | 04/30/2010SE |
Questions and answers
When was BiomarC Fiducial Marker cleared by the FDA?
BiomarC Fiducial Marker (K191797) received a 510(k) decision of Substantially Equivalent on July 29, 2019, 26 days after the submission was received.
What is the product code of K191797?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.