DeviceClearance

Product code LQK— Obstetrics/Gynecology

INVU by Nuvo

Classification name
Home Uterine Activity Monitor
Device class
Class 2
Regulation
21 CFR 884.2730
Advisory panel
Obstetrics/Gynecology
Total cleared
6
First cleared
Most recent

Market context for product code LQK

FDA has cleared 6 devices under product code LQK between 2002 and 2026, filed by 4 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 LQK

Recent clearances under product code LQK

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