510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K173533Substantially Equivalent

Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter

Poiesis Medical, LLC, Jupiter FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173533 is the FDA 510(k) clearance record for Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter, a class II device, cleared for Poiesis Medical, LLC on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list one 510(k) clearance for Poiesis Medical, LLC. As of , FDA records show no recalls naming K173533.

Clearance record

Decision date
Received
(134 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Poiesis Medical, LLC 1095 Jupiter Park Dr., Jupiter FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZL

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