MODIFIED FEEDING JEJUNOSTOMY TUBE— 510(k) K800918

Name: FDA 510(k) clearance K800918
Creator: U.S. Food and Drug Administration
Published: 1980-07-28

Substantially Equivalent

Mitchell V. Kaminski, Jr., M.D.

FDA 510(k) clearance K800918 for MODIFIED FEEDING JEJUNOSTOMY TUBE, Substantially Equivalent on 1980-07-28. Applicant: Mitchell V. Kaminski, Jr., M.D.. Device class: 2.

Clearance details

Applicant: Mitchell V. Kaminski, Jr., M.D.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1980-04-22
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code KNT

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K250389 — XNY Disposable Gastric Calibration Tube2025-04-10
K243228 — Flexi-Seal AIR (with ENFit Connector)2025-03-28
K242336 — hygh-tec Drainage II2025-01-17

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.