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FluidSmart

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172048

by Thermedx, LLC

Identifiers

510(k) Number
K172048 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)

FluidSmart is a hysteroscopic insufflator and fluid management system intended for irrigation, distention, fluid warming, and fluid volume or deficit measurement during endoscopic procedures. It is designed for use in gynecology, urology, and orthopedic disciplines to support laparoscopic and endoscopic interventions.

The device is supplied as a single-use system and is intended for sterile operation in clinical settings. It is classified under product code HIG and regulated under 21 CFR 884.1700. Storage conditions and handling should follow the manufacturer's operation manual, and the system is designed for single-patient use to maintain sterility and safety.

Frequently asked questions

What medical specialties can use the FluidSmart device, and how does it support their procedures?

The FluidSmart device is designed for use in gynecology, urology, and orthopedic disciplines, specifically to support laparoscopic and endoscopic interventions. It provides irrigation, distention, fluid warming, and precise volume or deficit measurement, which are critical for maintaining optimal visualization and fluid balance during hysteroscopic and insufflation-based procedures.

Is the FluidSmart system reusable or single-use, and how does this affect its clinical use?

The FluidSmart system is intended for single-use only and is designed for sterile operation in clinical settings. This ensures patient safety by preventing cross-contamination between procedures, as each system is dedicated to a single patient.

What storage conditions should be followed for the FluidSmart device to maintain its integrity?

Storage conditions and handling instructions are detailed in the manufacturer’s operation manual. While specific details aren’t provided here, the device is sterile upon packaging and must be stored according to the guidelines to preserve sterility and functionality before use.

How was the regulatory pathway for the FluidSmart device determined, and what does this mean for its use?

The FluidSmart device was cleared via an FDA 510(k) submission (K172048) under Special 510(k) review, with a substantially equivalent (SESE) determination by the Obstetrics/Gynecology (OB) Advisory Committee. This means it was compared to a legally marketed predicate device and deemed equivalent in safety and effectiveness for its intended uses in hysteroscopic insufflation and fluid management.

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: Thermedx FluidSmart Fluid management system - Stryker, PDF Fluid Management System FluidSmart Operation Manual, THERMEDX FLUIDSMART OPERATION MANUAL Pdf Download

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thermedx, LLC

Sources (1)

  • FDA 510(k) K172048 24 fields · synced Sep 19, 2026