510(k) clearance

LOBO Vascular Occlusion System

FDA 510(k) source

510(k) number

K262798

Applicant

Okami Medical, Inc.

Decision date

Oct 6, 2026

Date received

Aug 7, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KRD

Device type

Device, Vascular, For Promoting Embolization

Device class

Class II

Regulation

21 CFR 870.3300

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Aliso Viejo, CA, US