FALLER STYLET— 510(k) K130441

Substantially Equivalent

Medionics International, Inc.

FDA 510(k) clearance K130441 for FALLER STYLET, Substantially Equivalent on 2013-04-19. Applicant: Medionics International, Inc..

Clearance details

Applicant: Medionics International, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 2013-02-21
Decision date: 2013-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Markham, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.