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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Endolumik, Inc.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) 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. The listed applicant is Endolumik, Inc.. The 510(k) number is K222880.

When did Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) receive FDA 510(k) clearance?

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

Who is the listed applicant for Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)?

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

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.

Other records listing Endolumik, Inc. 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.

K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota 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, LLC

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.

↑