ENDOGATOR— 510(k) K092429

Substantially Equivalent

Byrne Medical, Inc.

FDA 510(k) clearance K092429 for ENDOGATOR, Substantially Equivalent on 2009-11-19. Applicant: Byrne Medical, Inc..

Clearance details

Applicant: Byrne Medical, Inc.
Product code: Code FEQ
Advisory panel: Gastroenterology, Urology
Date received: 2009-08-07
Decision date: 2009-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEQ

product code FEQ

Malfunction: 1,135
Total: 1,135

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.