PEW

Implantable Transprostatic Tissue Retractor System

Product code

PEW

Device name

Implantable Transprostatic Tissue Retractor System

Device class

Class 2

21 CFR

21 CFR 876.5530

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

11 (all years; only the last 3 years are listed here)

FDA classification definition

The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-22.