Product Code: PEW FDA class 2 21 CFR 876.5530

Implantable Transprostatic Tissue Retractor System

Gastroenterology, Urology

The Implantable Transprostatic Tissue Retractor System is a urology device indicated for the treatment of lower urinary tract symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men aged 45 years or older, using a minimally invasive approach to retract obstructing prostatic tissue. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.5530, requiring 510(k) premarket notification. As an implant, it is subject to general controls and special controls; it is not considered life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: PEW
Device Class: FDA class 2
Regulation Number: 876.5530
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232558	UroLift 2 ATC Advanced Tissue Control System	Sep 22, 2023	Substantially Equivalent	Neotract, Inc.
K201837	UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge	Jul 31, 2020	Substantially Equivalent	Neotract, Inc.
K200441	UroLift Advanced Tissue Control (ATC) System	Jun 05, 2020	Substantially Equivalent	Neotract, Inc.
K193269	UroLift System (UL400)	Dec 20, 2019	Substantially Equivalent	Neotract, Inc.
K190377	UroLift System UL400	Mar 21, 2019	Substantially Equivalent	Neotract, Inc.
K173087	UroLift System (UL400 and UL500)	Dec 28, 2017	Substantially Equivalent	Neotract, Inc.
K172359	UroLift System (UL500)	Aug 18, 2017	Substantially Equivalent	Neotract, Inc.
K162345	UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge	Sep 21, 2016	Substantially Equivalent	Neotract, Inc.
K153584	NeoTract UroLift System UL500	Mar 15, 2016	Substantially Equivalent	Neotract, Inc.
K133281	NEOTRACT UROLIFT SYSTEM	Dec 20, 2013	Substantially Equivalent	Neotract, Inc.
DEN130023	UROLIFT SYSTEM	Sep 13, 2013	Unknown	Neotract, Inc.