Product code NDS— Gastroenterology, Urology

AIM-V (R) MEDIUM, MODEL 087-0112

Classification name
Media, Culture, Ex Vivo, Tissue And Cell
Device class
Class 2
Regulation
21 CFR 876.5885
Advisory panel
Gastroenterology, Urology
Total cleared
9
First cleared
Most recent

Market context for product code NDS

FDA has cleared 9 devices under product code NDS between 2001 and 2024, filed by 7 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 NDS

Recent clearances under product code NDS

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