510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NYVClass II

Gastrointestinal Motility System, Capsule

21 CFR 876.1725 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NYV is the FDA product code for Gastrointestinal Motility System, Capsule, a class II device type, regulated under 21 CFR 876.1725. FDA's definition for this code reads: "Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NYV
Device name
Gastrointestinal Motility System, Capsule
FDA definition
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code NYV

By decision year
5 clearances under product code NYV with a decision year between 2006 and 2026, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NYV by decision year
YearClearances
20061
20091
20252
20261

Applicants with the most clearances

Product code NYV
Applicants holding the most 510(k) clearances under product code NYV
ApplicantClearances
Atmo Biosciences Ltd2
The Smartpill Corporation2
Anx Robotica Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code