MEDOVATIONS ESOPHAGEAL DILATOR— 510(k) K002363

Substantially Equivalent

Medovations, Inc.

FDA 510(k) clearance K002363 for MEDOVATIONS ESOPHAGEAL DILATOR, Substantially Equivalent on 2000-11-01. Applicant: Medovations, Inc..

Clearance details

Applicant: Medovations, Inc.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 2000-08-03
Decision date: 2000-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo Grove, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.