510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013276Substantially Equivalent

All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)

Sewoon Medical Co., Ltd., Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013276 is the FDA 510(k) clearance record for ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE), a class II device, cleared for Sewoon Medical Co., Ltd. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list one 510(k) clearance for Sewoon Medical Co., Ltd. As of , FDA records show no recalls naming K013276.

Clearance record

Decision date
Received
(137 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sewoon Medical Co., Ltd. P.O. Box 7007, Deer Field IL
510(k) summary
Summary
Third party review
No

Clearances, product code EZL

Trailing 12 months
3 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 20260