FluidSmart— 510(k) K172048

Clearance details

Applicant

Thermedx, LLC

Product code

Code HIG

Device class

Class 2

Regulation

21 CFR 884.1700

Advisory panel

Obstetrics/Gynecology

Date received

2017-07-06

Decision date

2017-09-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Solon, OH, US

• K261706 — Endomat Select (UP220)2026-07-16
• K251273 — Asurys Fluid Management System2026-03-27
• K240886 — Fluent Pro Fluid Management System (FLT-200) +4 more2024-07-25
• K210628 — X-FLO Fluid Management System2021-11-04
• K201355 — Endomat Select, IBS Shaver Software, License2020-07-22

• K133799 — THERMEDX FLUID MANAGMENT SYSTEM2014-06-20
• K102275 — THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH2402011-03-25
• K091939 — THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P20002010-07-23

Death

8

Other

2

Total

10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2166-2026 — Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.Class II·Ongoing·Stryker Corporation·20260409

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172048.