FDA 510(k)

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

Numéro K : K232028 · 2023-11-17

Date de décision2023-11-17

Code produitFDS

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : FDS)

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation 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

Source officielle

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