X-FLO Fluid Management System
510(k) K210628
X-FLO Fluid Management System is a medical device (FDA Class II; FDA product code HIG, Insufflator, Hysteroscopic) made by Thermedx, LLC, cleared under FDA 510(k) K210628 on 4 Nov 2021, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210628 | Date4 Nov 2021 | StatusActive |
Official records
- FDA 510(k) database K210628
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HIG
- Device class
- Class II
- Regulation
- 21 CFR Part 884.1700
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K210628
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ThermaClear 502500001 | 502500001 / 502500001 | 07613327626391 | — | On the market |
Similar devices
Other devices filed under FDA product code HIG (Insufflator, Hysteroscopic).
- THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR by Karl Storz Endoscopy-America, Inc.
- HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM by Davol Inc., Sub. C. R. Bard, Inc.
- CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP by Cabot Medical Corp.
- DAVOL SCOPE IRRIGATION SYSTEM by C. R. Bard, Inc.
- HYSTEROSCOPY PUMP HM6 by W.O.M. World of Medicine GmbH
- INSUFFLATOR TUBING by MEDLINE INDUSTRIES, INC.
- HYS-SURGIFLATOR 150P by W.O.M. World of Medicine GmbH
- BARD HYSTERO-FLO II PUMP by Davol Inc., Sub. C. R. Bard, Inc.
- HYSTEROFLATOR 1500 by F.M. Wiest USA, Inc.
- HYSTERO CO2-PNEU 2221 by RICHARD WOLF MEDICAL INSTRUMENTS CORP.