510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040110Substantially Equivalent

Easy Loop, Model Ezl-01

Tools for Surgery, LLC, Stony Brook NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040110 is the FDA 510(k) clearance record for EASY LOOP, MODEL EZL-01, a class II device, cleared for Tools For Surgery, LLC on under FDA product code EZP (Rod, Colostomy). FDA records list 4 510(k) clearances for Tools For Surgery, LLC, from to . As of , FDA records show no recalls naming K040110.

Clearance record

Decision date
Received
(64 days to decision)
Product code
EZP Rod, Colostomy
Regulation
21 CFR 876.4270
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Tools For Surgery, LLC 1339 Stony Brook Rd., Stony Brook NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZP

Trailing 12 months

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

FDA records show no clearances under product code EZP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZP, 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