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FluidSmart

by Thermedx, LLC

510(k) K172048

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK172048 Date5 Sep 2017ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2166-2026 FDA Class II initiated 9 Apr 2026

    Due to nonconforming products being inadvertently distributed.

Timeline

2 dated events

  1. Cleared FDA 510(k) K172048
  2. Recall initiated FDA recalls Z-2166-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K172048

1 device · FDA GUDID

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.

Devices cleared under K172048
UDI-DISize and differences
Urology Set LL0006
Thermedx, LLC
LL0006 / LL000600860936000365
Pressure 400 millibar
On the market

Similar devices

Other devices filed under FDA product code HIG (Insufflator, Hysteroscopic).

Other devices from Thermedx, LLC

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