Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®

K-Number: K261890 · 2026-08-14

ApplicantBoehringer Laboratories, LLC
Decision Date2026-08-14
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories, LLC. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K261890. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®?

52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Boehringer Laboratories, LLC. The 510(k) number is K261890.

When did 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® receive FDA 510(k) clearance?

52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® received FDA 510(k) clearance on 2026-08-14, under 510(k) number K261890.

Who is the listed applicant for 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®?

The FDA 510(k) record lists Boehringer Laboratories, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®?

The FDA product code for 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® is KNT.

Other records listing Boehringer Laboratories, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243399Boehringer Laboratories Liver RetractorK234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)K234145ViSiGi 3D Gastric Sizing Tube

Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLCK241169Entarik NI Feeding Tube SystemGravitas Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑