52Fr ViSiGi LUX; 52Fr ViSiGi 3D®— 510(k) K261890
Substantially EquivalentBoehringer 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.
Summary
Boehringer Laboratories' submission lists the 52Fr ViSiGi LUX and the 52Fr ViSiGi 3D. They're filed under product code KNT, gastrointestinal tubes and accessories.
Class II, 21 CFR 876.5980. Gastroenterology and Urology is both the classification panel and the review panel, and the submission type is Special.
Boehringer filed from Phoenixville, Pennsylvania. Review took 70 calendar days (June 5 to August 14, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- Boehringer Laboratories, LLC
- Product code
- Product code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Phoenixville, PA, US
Recent devices under product code KNT
view allMore clearances from Boehringer Laboratories, LLC
view allAdverse 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, through . 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.