The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Sanarus Core Tissue Biopsy System.
| Device ID | K003528 |
| 510k Number | K003528 |
| Device Name: | SANARUS CORE TISSUE BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Contact | Vincent Cutarelli |
| Correspondent | Vincent Cutarelli ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-16 |
| Decision Date | 2001-05-03 |