510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PEWClass II

Implantable Transprostatic Tissue Retractor System

21 CFR 876.5530 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PEW is the FDA product code for Implantable Transprostatic Tissue Retractor System, a class II device type, regulated under 21 CFR 876.5530. FDA's definition for this code reads: "The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PEW
Device name
Implantable Transprostatic Tissue Retractor System
FDA definition
The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Regulation
21 CFR 876.5530
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
2

Clearances, product code PEW

By decision year
11 clearances under product code PEW with a decision year between 2013 and 2023, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PEW by decision year
YearClearances
20132
20162
20172
20192
20202
20231

Applicants with the most clearances

Product code PEW
Applicants holding the most 510(k) clearances under product code PEW
ApplicantClearances
Neotract Inc11

Companies listing this code with FDA

Companies whose registered establishments list this code