DeviceClearance

Product code NYV— Gastroenterology, Urology

Atmo Gas Capsule System

Classification name
Gastrointestinal Motility System, Capsule
Device class
Class 2
Regulation
21 CFR 876.1725
Advisory panel
Gastroenterology, Urology
Total cleared
5
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NYV under 21 CFR 876.1725, via openFDA

Market context for product code NYV

FDA has cleared 5 devices under product code NYV between 2006 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NYV

Recent clearances under product code NYV

Data sourced from openFDA. This site is unofficial and independent of the FDA.