CRYOCARE SURGICAL SYSTEM
Unit, Cryosurgical, Accessories
ENDOCARE, INC.
The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Cryocare Surgical System.
Pre-market Notification Details
| Device ID | K003811 |
| 510k Number | K003811 |
| Device Name: | CRYOCARE SURGICAL SYSTEM |
| 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 | 2000-12-11 |
| Decision Date | 2001-10-11 |
Trademark Results [CRYOCARE SURGICAL SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOCARE SURGICAL SYSTEM 76140308 2753656 Dead/Cancelled |
Endocare, Inc. 2000-10-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.