PATTISON ESOPHAGEAL DILATOR— 510(k) K971615

Substantially Equivalent

Tri-Med Specialties, Inc.

FDA 510(k) clearance K971615 for PATTISON ESOPHAGEAL DILATOR, Substantially Equivalent on 1997-07-24. Applicant: Tri-Med Specialties, Inc..

Clearance details

Applicant: Tri-Med Specialties, Inc.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-02
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, 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.