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FDA 510(k)

GastroFlush

K-Number: K180605 · 2018-10-24

ApplicantBionix Development Corporation
Decision Date2018-10-24
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GastroFlush is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corporation. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K180605. 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 GastroFlush?

GastroFlush is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Bionix Development Corporation. The 510(k) number is K180605.

When did GastroFlush receive FDA 510(k) clearance?

GastroFlush received FDA 510(k) clearance on 2018-10-24, under 510(k) number K180605.

Who is the listed applicant for GastroFlush?

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

What is the FDA product code for GastroFlush?

The FDA product code for GastroFlush is KNT.

Other records listing Bionix Development Corporation 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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