FDA 510(k)

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

K-Number: K232028 · 2023-11-17

Decision Date2023-11-17

Product CodeFDS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is the device name listed in this FDA 510(k) record. The listed applicant is Iq Endoscopes Limited. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K232028. 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 Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Iq Endoscopes Limited. The 510(k) number is K232028.

When did Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) receive FDA 510(k) clearance?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) received FDA 510(k) clearance on 2023-11-17, under 510(k) number K232028.

Who is the listed applicant for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

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

What is the FDA product code for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

The FDA product code for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is FDS.

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.

NCT06771102Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute PatientsRECRUITING NCT07727226Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy UnitRECRUITING NCT04829461Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible CystoscopyCOMPLETED NCT06113939Prevention of Infection of the Respiratory Tract Through Application of Non-Invasive Methods of Secretion SuctioningNOT_YET_RECRUITING NCT06596655Single Use Bronchoscopes for Interventional PulmonologyRECRUITING NCT07745595Low Dose Aspirin vs Placebo in Prevention of Recurrent Spontaneous Preterm LabourNOT_YET_RECRUITING

Related Devices (Code: FDS)

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm Corporation K251256PENTAX 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.