Identity
- Trade Name
- Aquilex Fluid Control System FDA UDI
- Generic Name
- Hysteroscopic irrigation/insufflation system FDA UDI
- Model / Reference
- AQL-100PBS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056702006914 FDA UDI
- 510(k) Number
- K172040 FDA UDI
- FDA Product Code
- HIG FDA UDI
- GMDN Term
- Hysteroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Hysteroscopic irrigation/insufflation system
Aquilex Fluid Control System by W.O.M. World of Medicine GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hysteroscopic irrigation/insufflation system.
- Hayden Medical — Hayden Medical Inc · Class II
- Fluid Safe — Stryker Corp. · Class II
- TRUCLEARTM Calibration Insert 2.9 — Smith & Nephew, Inc. · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- TruClear — Covidien LP · Class II
- Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
- ThermaClear — Stryker Corp. · Class II
- Luer Lock Set, Single Lumen — Thermedx, LLC · Class II
Cleared under the same submission
K172040 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- W.O.M. World of Medicine GmbH
Sources (1)
- FDA UDI 28f7593a-5bfc-49a2-b124-9be400aa98d9 33 fields · synced May 30, 2026