510(k) K253514— Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)

Substantially Equivalent

C.R. Bard, Inc.

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-06
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

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.