510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K170233Substantially Equivalent

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)

Zhanjiang Star Enterprise Co., Ltd., Zhanjiang, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170233 is the FDA 510(k) clearance record for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter), a class II device, cleared for Zhanjiang Star Enterprise Co., Ltd. on under FDA product code EZD (Catheter, Straight). FDA records list 2 510(k) clearances for Zhanjiang Star Enterprise Co., Ltd., from to . As of , FDA records show no recalls naming K170233.

Clearance record

Decision date
Received
(261 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Zhanjiang Star Enterprise Co., Ltd. #1, W. Jinhua Rd., Zhanjiang, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZD

Trailing 12 months
11 clearances under product code EZD in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20261
April 20262
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260