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FDA 510(k)

Endofresh Digestive Endoscopy System

K-Number: K192704 · 2020-09-02

ApplicantHuizhou Xzing Technology Co., Ltd.
Decision Date2020-09-02
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endofresh Digestive Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Xzing Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K192704. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endofresh Digestive Endoscopy System?

Endofresh Digestive Endoscopy System is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Huizhou Xzing Technology Co., Ltd.. The 510(k) number is K192704.

When did Endofresh Digestive Endoscopy System receive FDA 510(k) clearance?

Endofresh Digestive Endoscopy System received FDA 510(k) clearance on 2020-09-02, under 510(k) number K192704.

Who is the listed applicant for Endofresh Digestive Endoscopy System?

The FDA 510(k) record lists Huizhou Xzing Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endofresh Digestive Endoscopy System?

The FDA product code for Endofresh Digestive Endoscopy System is FDS.

Related Devices (Code: FDS)

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.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm CorporationK253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm CorporationK251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.

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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