Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

QKA · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5510

Classification

FDA Product Code: QKA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5510
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 7

Source

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