K251852

Substantially Equivalent

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

Applicant: VPIX Medical, Inc.
Product code: OWN
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-17
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

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.