ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285— 510(k) K083685

Substantially Equivalent

Mri Manufacturing and Research, Inc.

FDA 510(k) clearance K083685 for ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285, Substantially Equivalent on 2009-06-25. Applicant: Mri Manufacturing and Research, Inc..

Clearance details

Applicant: Mri Manufacturing and Research, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-12
Decision date: 2009-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, 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.