SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)— 510(k) K041034

Substantially Equivalent

Entracare, LLC

FDA 510(k) clearance K041034 for SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL), Substantially Equivalent on 2004-08-31. Applicant: Entracare, LLC.

Clearance details

Applicant: Entracare, LLC
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2004-04-21
Decision date: 2004-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.