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FDA 510(k)

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

K-Number: K222880 · 2023-03-03

ApplicantEndolumik, Inc.
Decision Date2023-03-03
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is a medical device manufactured by Endolumik, Inc.. It received FDA 510(k) clearance on 2023-03-03 under approval number K222880. 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 Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)?

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is a medical device that received FDA 510(k) clearance on 2023-03-03. It is manufactured by Endolumik, Inc.. The 510(k) number is K222880.

When was Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) approved by the FDA?

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) received FDA 510(k) clearance on 2023-03-03, under approval number K222880.

What company makes Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)?

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is manufactured by Endolumik, Inc..

What is the FDA product code for Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)?

The FDA product code for Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is KNT.

Related Clinical Trials

NCT07572058 Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration System NOT_YET_RECRUITING NCT06174805 AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE SUSPENDED NCT07565857 Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer NOT_YET_RECRUITING NCT07533825 Laparoscopic Staging for Stage III Gastric Cancer ENROLLING_BY_INVITATION NCT05593523 Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes ACTIVE_NOT_RECRUITING

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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.

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