The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Surgical System With Cryoguide.
| Device ID | K002615 |
| 510k Number | K002615 |
| Device Name: | SURGICAL SYSTEM WITH CRYOGUIDE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Contact | Vincent Cutarelli |
| Correspondent | Vincent Cutarelli ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-22 |
| Decision Date | 2000-11-13 |