EndoCore— 510(k) K230778

Name: FDA 510(k) clearance K230778
Creator: U.S. Food and Drug Administration
Published: 2023-09-25

Substantially Equivalent

Praxis Medical, LLC

FDA 510(k) clearance K230778 for EndoCore, Substantially Equivalent on 2023-09-25. Applicant: Praxis Medical, LLC. Device class: 2.

Clearance details

Applicant: Praxis Medical, LLC
Product code: Code KTI
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2023-03-21
Decision date: 2023-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

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.