Portare System (FA-001)— 510(k) K243639

Substantially Equivalent

Grumpy Innovation, Inc.

FDA 510(k) clearance K243639 for Portare System (FA-001), Substantially Equivalent on 2025-06-05. Applicant: Grumpy Innovation, Inc..

Clearance details

Applicant: Grumpy Innovation, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2024-11-25
Decision date: 2025-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.