510(k) K223031

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

January 13, 2023

Date Received

September 29, 2022

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Orally Ingested Transient Device For Constipation

Device Class

Class II

Regulation Number

876.5940

Review Panel

GU

Submission Type

An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.