SURGITEK PERCUTANEOUS NEPHROSTOMY CATH— 510(k) K830226

Substantially Equivalent

Medical Engineering Corp.

FDA 510(k) clearance K830226 for SURGITEK PERCUTANEOUS NEPHROSTOMY CATH, Substantially Equivalent on 1983-02-09. Applicant: Medical Engineering Corp..

Clearance details

Applicant: Medical Engineering Corp.
Product code: Code LJE
Advisory panel: Unknown
Date received: 1983-01-24
Decision date: 1983-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

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.