ClariFix
Unit, Cryosurgical, Accessories
Arrinex, Inc
The following data is part of a premarket notification filed by Arrinex, Inc with the FDA for Clarifix.
Pre-market Notification Details
| Device ID | K190356 |
| 510k Number | K190356 |
| Device Name: | ClariFix |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Arrinex, Inc 127 Independence Drive Menlo Park, CA 94025 |
| Contact | Tracey Henry |
| Correspondent | Tracey Henry Arrinex, Inc 127 Independence Drive Menlo Park, CA 94025 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2019-02-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868438000258 | K190356 | 000 |
| 00868438000234 | K190356 | 000 |
| 00850002250411 | K190356 | 000 |
| 00850002250404 | K190356 | 000 |
Trademark Results [ClariFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLARIFIX 86947753 5196955 Live/Registered |
Arrinex, Inc. 2016-03-21 |
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