Aer-O-Scope Colonoscope System— 510(k) K230588

Name: FDA 510(k) clearance K230588
Creator: U.S. Food and Drug Administration
Published: 2023-08-17

Substantially Equivalent

Gi View , Ltd.

FDA 510(k) clearance K230588 for Aer-O-Scope Colonoscope System, Substantially Equivalent on 2023-08-17. Applicant: Gi View , Ltd.. Device class: 2.

Clearance details

Applicant: Gi View , Ltd.
Product code: Product code FDF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-03-02
Decision date: 2023-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat Gan, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code FDF

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K260503 — Triton 1 System2026-09-03
K261015 — Solo Scope Colonoscope System2026-08-21
K261587 — Insufflation Retention Device (IRD) (11173-325-101)2026-07-02
K260423 — Disposable Endoscopic Distal Attachments2026-05-28
K252457 — Disposable Distal End Tape Hood2026-01-30

More clearances from Gi View , Ltd.

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K161791 — Aer-O-Scope Colonoscope System2016-08-11
K141286 — AER-O-SCOPE COLONOSCOPE SYSTEM2014-09-30

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.