EndoflipTM 300— 510(k) K223705

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K223705 for EndoflipTM 300, Substantially Equivalent on 2023-04-14. Applicant: Covidien, LLC.

Clearance details

Applicant
Covidien, LLC
Product code
Code FFX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Clara, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FFX

product code FFX
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.