Cleared Special

K261890 - 52Fr ViSiGi LUX™

Also marketed or referenced as:
52Fr ViSiGi 3D®

K261890 is an FDA 510(k) clearance for 52Fr ViSiGi LUX, manufactured by Boehringer Laboratories, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Special 510(k) pathway after a 70-day FDA review.

K261890 · Boehringer Laboratories, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
70d
Days
Class 2
Risk

K261890 is an FDA 510(k) clearance for the 52Fr ViSiGi LUX™. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Boehringer Laboratories, LLC (Phoenixville, US). The FDA issued a Cleared decision on August 14, 2026 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boehringer Laboratories, LLC devices

FDA 510(k) Submission Details - K261890

510(k) Number K261890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2026
Decision Date August 14, 2026
Days to Decision 70 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K261890.
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220)
K253514 · C.R. Bard, Inc. · Jul 2026
XNY Disposable Gastric Calibration Tube
K250389 · Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · Apr 2025
Flexi-Seal AIR (with ENFit Connector)
K243228 · Convatec · Mar 2025
hygh-tec Drainage II
K242336 · Amb Medtec · Jan 2025
ZZIREN™ Orogastric Tube
K242901 · Tools For Surgery, LLC · Jan 2025
Entarik NI Feeding Tube System
K241169 · Gravitas Medical, Inc. · Nov 2024