JACKSON ESOPHAGEAL DILATOR— 510(k) K990935

Name: FDA 510(k) clearance K990935
Creator: U.S. Food and Drug Administration
Published: 1999-05-17

Substantially Equivalent

Pilling Weck Surgical

FDA 510(k) clearance K990935 for JACKSON ESOPHAGEAL DILATOR, Substantially Equivalent on 1999-05-17. Applicant: Pilling Weck Surgical. Device class: 2.

Clearance details

Applicant: Pilling Weck Surgical
Product code: Code KNQ
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 1999-03-19
Decision date: 1999-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Washington, PA, US

Download summary PDF View on FDA.gov ↗

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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.