GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
Device Facts
| Record ID | K000060 |
|---|---|
| Device Name | GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 |
| Applicant | Senorx, Inc. |
| Product Code | GDW · General, Plastic Surgery |
| Decision Date | Mar 27, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.
