NYV

Gastrointestinal Motility System, Capsule

Product code
NYV
Device name
Gastrointestinal Motility System, Capsule
Device class
Class 2
21 CFR
21 CFR 876.1725
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
5 (all years; only the last 3 years are listed here)

FDA classification definition

Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-05-22.

NumberDecision dateApplicantDevice nameSummary
K2535692026-05-22Atmo Biosciences, Ltd.Atmo Gas Capsule SystemPDF
K2509402025-06-26Atmo Biosciences, Ltd.Atmo Gas Capsule SystemPDF
K2504932025-05-21Anx Robotica CorporationMotiliCap GI Monitoring SystemPDF

3 summaries are archived here for direct download.

Official FDA classification page: NYV
Classification and pathway per current FDA publications. Data from openFDA (CC0).