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.. Device class: 2.

Clearance details

Applicant
VPIX Medical, Inc.
Product code
Code GWG
Device class
Class 2
Regulation
21 CFR 882.1480
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Daejeon, KR
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GWG

product code GWG
Death
5
Total
5

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.