510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K153506Substantially Equivalent

Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

Consure Medical Pvt, Ltd., New Delhi, IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153506 is the FDA 510(k) clearance record for Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit, a class II device, cleared for Consure Medical Pvt , Ltd. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 2 510(k) clearances for Consure Medical Pvt , Ltd., from to . As of , FDA records show no recalls naming K153506.

Clearance record

Decision date
Received
(151 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Consure Medical Pvt , Ltd. 5l, Third Floor, Shahpur Jat, New Delhi, IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNT

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