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Fluent Pro Fluid Management System
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref FLT-200510(k) K240886
by Hologic Inc
Identity
- Trade Name
- Fluent Pro Fluid Management System EUDAMEDFDA UDI
- Generic Name
- Hysteroscopic irrigation/insufflation system FDA UDI
- Device Name
- Fluent Pro Fluid Management System EUDAMEDThe Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation liquid flowing into and out of the uterus while providing drive, control, and suction for hysteroscopic morcellators. FDA UDI
- Model / Reference
- FLT-200 EUDAMEDFDA UDI
- Description
- The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation liquid flowing into and out of the uterus while providing drive, control, and suction for hysteroscopic morcellators. FDA UDI
Identifiers
- Catalog Number
- FLT-200 FDA UDI
- Primary DI / UDI-DI
- 15420045516212 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455GSSFLUENTSYSZL EUDAMED
- Direct Marketing DI
- 15420045516212 EUDAMED
- 510(k) Number
- K240886 FDA UDI
- FDA Product Code
- HIG FDA UDIHIH FDA UDI
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
- GMDN Term
- Hysteroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1700 FDA UDI884.1690 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fluent Pro Fluid Management System by Hologic Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240886 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 54200455GSSFLUENTSYSZL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hologic Inc
- EUDAMED SRN
- US-MF-000003310
- FDA Applicant
- Hologic, Inc.
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (3)
- EUDAMED e25a2003-e4f3-4ead-b0d0-d646512a113a 85 fields · synced Jun 18, 2026
- FDA UDI a9ee74af-56b0-4117-a692-d0cc6aa91af6 37 fields · synced May 29, 2026
- FDA 510(k) K240886 1 fields · synced May 18, 2026