cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)— 510(k) K251852

Name: FDA 510(k) clearance K251852
Creator: U.S. Food and Drug Administration
Published: 2026-02-13

Substantially Equivalent

VPIX Medical, Inc.

FDA 510(k) clearance K251852 for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200), Substantially Equivalent on 2026-02-13. Applicant: VPIX Medical, Inc.. Device class: 2.

Clearance details

Applicant: VPIX Medical, Inc.
Product code: Code OWN
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-17
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

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.