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510(k) K091939

THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 by Thermedx, LLC — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2010
Date Received
June 30, 2009
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

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  • K102275 — THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH2 (March 25, 2011)

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  • K180735 — Endomat Select (October 31, 2018)
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  • K172040 — Aquilex Fluid Control System AQL-100S (February 5, 2018)
  • K172048 — FluidSmart (September 5, 2017)
  • K133799 — THERMEDX FLUID MANAGMENT SYSTEM (June 20, 2014)