Aquilex Fluid Control System H112
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112642 FDA 510(k)
- FDA Product Code
- HIG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1700 FDA 510(k)
- Regulation Number
- 884.1700 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aquilex Fluid Control System H112 is a hysteroscopic insufflator designed to provide controlled uterine distension during diagnostic and operative hysteroscopy. It delivers irrigation fluid into the uterus while simultaneously monitoring the volume differential between inflow and outflow, ensuring precise fluid management for procedural clarity and safety.
This system is intended for single-use in obstetrics and gynecology settings and has received FDA 510(k) clearance under the Traditional pathway. Supplied sterile, it is classified as a Class II device under FDA regulation 884.1700. The device is intended for use with compatible hysteroscopic instruments and adheres to MRI safety standards for non-ferromagnetic components. Storage and handling follow standard sterile medical device protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AQUILEX FLUID CONTROL SYSTEM H112 (K112642) — FDA 510(k) | Innolitics, PDF SUMMARY OF SAFETY & EFFECTIVENESS Submitter: W.O.M. WORLD OF MEDICINE, fda.innolitics.com, AQUILEX FLUID CONTROL SYSTEM H112 (K112642) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112642 | Class II | Active |
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Manufacturer
- Manufacturer
- W.O.M. World of Medicine AG
Sources (1)
- FDA 510(k) K112642 24 fields · synced Oct 5, 2026