510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093718Substantially Equivalent

Zutron Medical Endoscope Leak Tester Model Zutr-10003

Zutron Medical, Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093718 is the FDA 510(k) clearance record for ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003, a class I device, cleared for Zutron Medical, LLC on under FDA product code FCY (Bulb, Inflation, For Endoscope). FDA's definition for product code FCY reads: "An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles". FDA records list 2 510(k) clearances for Zutron Medical, LLC, from to . As of , FDA records show no recalls naming K093718.

Clearance record

Decision date
Received
(82 days to decision)
Product code
FCY Bulb, Inflation, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Zutron Medical, LLC 9816 Pflumm Rd., Lenexa KS
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCY

Trailing 12 months

FDA records hold no clearances under product code FCY in the trailing twelve months.

FDA records show no clearances under product code FCY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260