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

Name: FDA 510(k) clearance K083685
Creator: U.S. Food and Drug Administration
Published: 2009-06-25

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.. Device class: 2.

Clearance details

Applicant: Mri Manufacturing and Research, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-12
Decision date: 2009-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNT

view all

K261890 — 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®2026-08-14
K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more2026-07-10
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

More clearances from Mri Manufacturing and Research, Inc.

view all

K982970 — MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER1998-10-28
K944676 — MRI'S ALL SILICONE FOLEY CATHETER1996-04-05

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.