The following data is part of a premarket notification filed by Arrinex, Inc. with the FDA for Clarifix Device.
| Device ID | K162608 |
| 510k Number | K162608 |
| Device Name: | ClariFix Device |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ARRINEX, INC. 1755 EAST BAYSHORE RD, STE 26 Redwood City, CA 94063 |
| Contact | Vahid Saadat |
| Correspondent | Vahid Saadat ARRINEX, INC. 1755 EAST BAYSHORE RD, STE 26 Redwood City, CA 94063 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2017-02-14 |
| Summary: | summary |