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510(k) K210628

X-FLO Fluid Management System by Thermedx, LLC — Product Code HIG

K210628 is an FDA 510(k) premarket notification submitted by Thermedx, LLC for the device "X-FLO Fluid Management System". The FDA issued a decision of Substantially Equivalent on November 4, 2021. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Thermedx, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2021
Date Received
March 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

Other clearances by Thermedx, LLC

  • K172048 — FluidSmart (September 5, 2017)
  • K133799 — THERMEDX FLUID MANAGMENT SYSTEM (June 20, 2014)
  • K102275 — THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH2 (March 25, 2011)
  • K091939 — THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 (July 23, 2010)

Other clearances for product code HIG

  • K261706 — Endomat Select (UP220) (July 16, 2026)
  • K251273 — Asurys Fluid Management System (March 27, 2026)
  • K240886 — Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System (July 25, 2024)
  • K201355 — Endomat Select, IBS Shaver Software, License (July 22, 2020)
  • K180735 — Endomat Select (October 31, 2018)
  • K180825 — Fluent Fluid Management System (August 3, 2018)
  • K173489 — GYN-Pump PH304 (March 28, 2018)
  • K172040 — Aquilex Fluid Control System AQL-100S (February 5, 2018)
  • K172048 — FluidSmart (September 5, 2017)
  • K133799 — THERMEDX FLUID MANAGMENT SYSTEM (June 20, 2014)

FDA data resources