TRI-MED INFLATABLE ESOPHAGEAL DILATOR— 510(k) K932015

Substantially Equivalent

Tri-Med Specialties, Inc.

FDA 510(k) clearance K932015 for TRI-MED INFLATABLE ESOPHAGEAL DILATOR, Substantially Equivalent on 1994-02-03. Applicant: Tri-Med Specialties, Inc..

Clearance details

Applicant: Tri-Med Specialties, Inc.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1993-04-23
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

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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.