Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

NOY · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5550

Classification

FDA Product Code: NOY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5550
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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).

Market data

Cleared 510(k) submissions: 4
Registered establishments: 11

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown