The following data is part of a premarket notification filed by Thermedx, Llc with the FDA for X-flo Fluid Management System.
| Device ID | K210628 |
| 510k Number | K210628 |
| Device Name: | X-FLO Fluid Management System |
| Classification | Insufflator, Hysteroscopic |
| Applicant | Thermedx, LLC 31200 Solon Rd Unit 1 Solon, OH 44139 |
| Contact | Daniel Marijian |
| Correspondent | Daniel Marijian Thermedx, LLC 31200 Solon Rd Unit 1 Solon, OH 44139 |
| Product Code | HIG |
| Subsequent Product Code | HRX |
| Subsequent Product Code | LGZ |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-02 |
| Decision Date | 2021-11-04 |