SLIP UROLOGY CATHETER— 510(k) K040519

Name: FDA 510(k) clearance K040519
Creator: U.S. Food and Drug Administration
Published: 2004-05-20

Substantially Equivalent

Percutaneous Systems, Inc.

FDA 510(k) clearance K040519 for SLIP UROLOGY CATHETER, Substantially Equivalent on 2004-05-20. Applicant: Percutaneous Systems, Inc.. Device class: 2.

Clearance details

Applicant: Percutaneous Systems, Inc.
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-27
Decision date: 2004-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K052134 — CYSTOGLIDE DILATING INTRODUCER SHEATH2005-09-22
K042877 — MICROVERTER URETERAL ACCESS SHEATH2004-11-16
K040520 — SLIP UROLOGY INTRODUCER SHEATH2004-05-20

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.