K080698 is an FDA 510(k) clearance for the GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on March 31, 2008, 19 days after receiving the submission on March 12, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K080698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2008 |
| Decision Date | March 31, 2008 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEU — Marker, Radiographic, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |