Su2ura Approximation Device— 510(k) K201744

Name: FDA 510(k) clearance K201744
Creator: U.S. Food and Drug Administration
Published: 2021-06-17

Substantially Equivalent

Anchora Medical, Ltd.

FDA 510(k) clearance K201744 for Su2ura Approximation Device, Substantially Equivalent on 2021-06-17. Applicant: Anchora Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Anchora Medical, Ltd.
Product code: Code OCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-06-25
Decision date: 2021-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: I.Z. Yokneam, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.