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Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222880

by Endolumik, Inc.

Identifiers

510(k) Number
K222880 FDA 510(k)
FDA Product Code
KNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Endolumik Fluorescence-Guided Gastric Calibration Tube (FG Bougie) is a gastric calibration tube designed for fluorescence-guided visualization during surgical procedures. It combines traditional bougie functionality with real-time imaging to enhance precision in gastric and bariatric interventions, ensuring accurate tube placement and leak detection.

This device is intended for use in gastric and bariatric surgeries, enabling suction, decompression, drainage, irrigation, and leak testing. Supplied as a single-use, sterile product, it is regulated under FDA 510(k) clearance (K222880) and is classified under the product code KNT. Its fluorescence guidance feature aids in confirming tube positioning intraoperatively, improving procedural safety and reliability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Endolumik - Precisely Visualize Surgical Procedures, Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie), Products - Endolumik, A191 Trial of Fluorescence Guided Gastric Calibration Tube for Sleeve ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Endolumik, Inc.

Sources (1)

  • FDA 510(k) K222880 24 fields · synced Oct 6, 2026