510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091939Substantially Equivalent

Thermedx Prodigy Fluid Management System, Models P1000, P2000

Thermedx LLC, Solon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091939 is the FDA 510(k) clearance record for THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000, a class II device, cleared for Thermedx, LLC on under FDA product code HIG (Insufflator, Hysteroscopic). FDA records list 5 510(k) clearances for Thermedx, LLC, from to . As of , FDA records show 2 recalls naming K091939.

Clearance record

Decision date
Received
(388 days to decision)
Product code
HIG Insufflator, Hysteroscopic
Regulation
21 CFR 884.1700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Thermedx, LLC 31200 Solon Rd., Unit 1, Solon OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIG

Trailing 12 months
2 clearances under product code HIG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260