Gastric Lightguide (GLG)— 510(k) K212407

Substantially Equivalent

Naser Dib Gabinet Lekarksi Nasmed

FDA 510(k) clearance K212407 for Gastric Lightguide (GLG), Substantially Equivalent on 2022-07-26. Applicant: Naser Dib Gabinet Lekarksi Nasmed.

Clearance details

Applicant: Naser Dib Gabinet Lekarksi Nasmed
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2021-08-03
Decision date: 2022-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warszawa, PL

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.