cCeLL - In vivo— 510(k) K233391

Substantially Equivalent

VPIX Medical, Inc.

FDA 510(k) clearance K233391 for cCeLL - In vivo, Substantially Equivalent on 2024-08-21. Applicant: VPIX Medical, Inc..

Clearance details

Applicant: VPIX Medical, Inc.
Product code: Code GWG
Advisory panel: Neurology
Date received: 2023-10-02
Decision date: 2024-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.