MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS— 510(k) K881478

Substantially Equivalent

Keymed (Medical & Industrial Equipment), Ltd.

FDA 510(k) clearance K881478 for MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS, Substantially Equivalent on 1988-09-14. Applicant: Keymed (Medical & Industrial Equipment), Ltd..

Clearance details

Applicant: Keymed (Medical & Industrial Equipment), Ltd.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-06
Decision date: 1988-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Essex, GB

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.