DeviceClearance

Product code NOY— Gastroenterology, Urology

Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)

Classification name
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Device class
Class 2
Regulation
21 CFR 876.5550
Advisory panel
Gastroenterology, Urology
Total cleared
4
First cleared
Most recent

FDA classification definition

“The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).”

— U.S. Food and Drug Administration, device classification record for product code NOY under 21 CFR 876.5550, via openFDA

Market context for product code NOY

FDA has cleared 4 devices under product code NOY between 2017 and 2021, 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 NOY

Recent clearances under product code NOY

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