The following data is part of a premarket notification filed by Cryoconcepts Lp with the FDA for Cryomega Flexx.
| Device ID | K172769 |
| 510k Number | K172769 |
| Device Name: | CryOmega Flexx |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CryoConcepts LP 205 Webster Street Bethlehem, PA 18015 |
| Contact | R Sam Niedbala |
| Correspondent | R Sam Niedbala CryoConcepts LP 205 Webster Street Bethlehem, PA 18015 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-13 |
| Decision Date | 2017-11-30 |
| Summary: | summary |