GASTROINTESTINAL DILATOR— 510(k) K841310

Name: FDA 510(k) clearance K841310
Creator: U.S. Food and Drug Administration
Published: 1984-07-31

Substantially Equivalent

Thomas J. Fogarty, M.D.

FDA 510(k) clearance K841310 for GASTROINTESTINAL DILATOR, Substantially Equivalent on 1984-07-31. Applicant: Thomas J. Fogarty, M.D.. Device class: 2.

Clearance details

Applicant: Thomas J. Fogarty, M.D.
Product code: Code KNQ
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 1984-03-30
Decision date: 1984-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Thomas J. Fogarty, M.D.

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K884154 — TRANSLUMINAL ENDARTERECTOMY DEVICE1988-12-27
K831809 — FOGARTY OCCLUDER PAD1984-08-27
K834451 — COAXIAL BALLOON GASTROESOPHAGEAL DILA1984-02-04
K831384 — COAXIAL BALLOON URETHRAL DILATOR1983-07-26

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.