Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)— 510(k) K222880

Substantially Equivalent

Endolumik, Inc.

FDA 510(k) clearance K222880 for Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie), Substantially Equivalent on 2023-03-03. Applicant: Endolumik, Inc..

Clearance details

Applicant: Endolumik, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-22
Decision date: 2023-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgantown, WV, 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.