FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT— 510(k) K885339

Substantially Equivalent

Superior Healthcare Group, Inc.

FDA 510(k) clearance K885339 for FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT, Substantially Equivalent on 1989-03-01. Applicant: Superior Healthcare Group, Inc..

Clearance details

Applicant: Superior Healthcare Group, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1988-12-28
Decision date: 1989-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland, RI, US

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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.