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FDA 510(k)

ViSiGi 3D Gastric Sizing Tube

K-Number: K234145 · 2024-01-26

ApplicantBoehringer Laboratories
Decision Date2024-01-26
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ViSiGi 3D Gastric Sizing Tube is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K234145. 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 ViSiGi 3D Gastric Sizing Tube?

ViSiGi 3D Gastric Sizing Tube is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Boehringer Laboratories. The 510(k) number is K234145.

When did ViSiGi 3D Gastric Sizing Tube receive FDA 510(k) clearance?

ViSiGi 3D Gastric Sizing Tube received FDA 510(k) clearance on 2024-01-26, under 510(k) number K234145.

Who is the listed applicant for ViSiGi 3D Gastric Sizing Tube?

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

What is the FDA product code for ViSiGi 3D Gastric Sizing Tube?

The FDA product code for ViSiGi 3D Gastric Sizing Tube is KNT.

Related Clinical Trials

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.

NCT07572058Large Diameter ViSiGi LUX ™ Gastric Sizing and Calibration SystemNOT_YET_RECRUITING

Other records listing Boehringer Laboratories 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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®K243399Boehringer Laboratories Liver RetractorK234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)

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.

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