ENDO-GLIDE GUIDEWIRE— 510(k) K023603

Substantially Equivalent

Endo-Therapeutics, Inc.

FDA 510(k) clearance K023603 for ENDO-GLIDE GUIDEWIRE, Substantially Equivalent on 2003-02-19. Applicant: Endo-Therapeutics, Inc..

Clearance details

Applicant: Endo-Therapeutics, Inc.
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 2002-10-28
Decision date: 2003-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Safety Harbor, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.