Capso Vision, Inc.

FDA Regulatory Profile

Capso Vision, Inc. appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2536-2020, Class II) was initiated on February 26, 2020.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2536-2020Class IIThe CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; February 26, 2020
Z-1827-2020Class IICapsoCAM Plus, UDI: 00867770000209October 18, 2019
Z-2073-2020Class IICapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10July 3, 2019