Biomarc Gold Tissue Marker
FDA 510(k) K070436 · Carbon Medical Technologies, Inc.
510(k) numberK070436
Submission
- Device name
- Biomarc Gold Tissue Marker
- Applicant
- Carbon Medical Technologies, Inc.
St. Paul, MN, US - Received
- February 15, 2007
- Decision date
- March 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | Devicor Medical Products, Inc. | 01/23/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | Stryker Endoscopy | 12/31/2025SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | Merit Medical Systems, Inc. | 12/19/2025SE |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional | Breast-Med, Inc. | 12/12/2025SE |
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | Carbon Medical Technologies, Inc. | 07/23/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/24/2025SE |
| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | Inrad, Inc. | 11/07/2024SE |
| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
More from Molli Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253598 | InjecSURE Injection SystemFBK · Traditional | 03/31/2026SE |
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | 07/23/2025SE |
| K211590 | Fiducial MarkerIYE · Special | 06/10/2021SE |
| K191797 | BiomarC Fiducial MarkerIYE · Special | 07/29/2019SE |
| 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 |
Questions and answers
When was Biomarc Gold Tissue Marker cleared by the FDA?
Biomarc Gold Tissue Marker (K070436) received a 510(k) decision of Substantially Equivalent on March 16, 2007, 29 days after the submission was received.
What is the product code of K070436?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.