The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Cryocare Touch System And Accessories, Endocare 1.7mm Round Ice Percryo Cryoprobe, Short, Round Ice.
| Device ID | K201588 |
| 510k Number | K201588 |
| Device Name: | CRYOCARE TOUCH System And Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-12 |
| Decision Date | 2020-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810563020649 | K201588 | 000 |
| 00810563021684 | K201588 | 000 |
| 00810563020670 | K201588 | 000 |