ENDOPORT 5MM— 510(k) K852031

Substantially Equivalent

Endotherapeutics

FDA 510(k) clearance K852031 for ENDOPORT 5MM, Substantially Equivalent on 1985-08-13. Applicant: Endotherapeutics.

Clearance details

Applicant: Endotherapeutics
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1985-05-09
Decision date: 1985-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.