Habib EndoHPB— 510(k) K231533

Name: FDA 510(k) clearance K231533
Creator: U.S. Food and Drug Administration
Published: 2023-06-21

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K231533 for Habib EndoHPB, Substantially Equivalent on 2023-06-21. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2023-05-26
Decision date: 2023-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.