L.T.C. FEEDING TUBE— 510(k) K895616

Name: FDA 510(k) clearance K895616
Creator: U.S. Food and Drug Administration
Published: 1989-10-24

Substantially Equivalent

Intl. Medical Marketing, Inc.

FDA 510(k) clearance K895616 for L.T.C. FEEDING TUBE, Substantially Equivalent on 1989-10-24. Applicant: Intl. Medical Marketing, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Medical Marketing, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1989-09-19
Decision date: 1989-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridge, NY, US

Download summary PDF View on FDA.gov ↗

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K897181 — L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE1990-03-27
K895824 — L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET1990-03-13
K896621 — L.T.C. REPLACEMENT GASTROSTOMY TUBE1990-03-13
K895957 — L.T.C. 1000 URINARY DRAINAGE BAG1989-10-24

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.