52Fr ViSiGi LUX; 52Fr ViSiGi 3D®— 510(k) K261890

Name: FDA 510(k) clearance K261890
Creator: U.S. Food and Drug Administration
Published: 2026-08-14

Substantially Equivalent

Boehringer Laboratories, LLC

FDA 510(k) clearance K261890 for 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®, Substantially Equivalent on 2026-08-14. Applicant: Boehringer Laboratories, LLC. Device class: 2.

Clearance details

Applicant: Boehringer Laboratories, LLC
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2026-06-05
Decision date: 2026-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Phoenixville, PA, US

Download summary PDF View on FDA.gov ↗

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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.