Cleared Traditional

ViSiGi LUX (5332) (K234033) - FDA 510(k) Clearance

Also marketed or referenced as:
ViSiGi LUX (5336) ViSiGi LUX (5340)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234033 · Boehringer Laboratories, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
138d
Days
Class 2
Risk

K234033 is an FDA 510(k) clearance for the ViSiGi LUX (5332). 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 May 6, 2024 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Laboratories, LLC devices

Submission Details

510(k) Number K234033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2023
Decision Date May 06, 2024
Days to Decision 138 days
Submission Type Traditional
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
8d slower than avg
Panel avg: 130d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K234033.
CORTRAK* 2 Enteral Access System (20-0950)
K240965 · Avanos Medical, Inc. · Jun 2024
Stylus
K233591 · Degania Silicone , Ltd. · May 2024
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
K241039 · Reshape Lifesciences · May 2024
Enteral Feeding Sets
K240039 · Hangzhou Primecare Medical Co., Ltd. · Apr 2024
Endolumik Gastric Calibration Tube M Series (EGCT36M)
K240069 · Endolumik · Feb 2024
ViSiGi 3D Gastric Sizing Tube
K234145 · Boehringer Laboratories · Jan 2024