FDA 510(k) clearance · back to tracker

Silicone Urethral Catheter (Silicone Urethral Catheter)

Guangdong Ecan Medical Co., Ltd. cleared K243011 on 2025-06-16, decision: substantially equivalent

K-number

K243011

Sponsor

Guangdong Ecan Medical Co., Ltd.

Device

Silicone Urethral Catheter (Silicone Urethral Catheter)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-06-16

Product code

EZL

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5130

Official FDA record

Open K243011on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K243011 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.