UroLift System UL400
FDA 510(k) K190377 · Neotract, Inc.
510(k) numberK190377
Submission
- Device name
- UroLift System UL400
- Applicant
- Neotract, Inc.
Pleasanton, CA, US - Received
- February 19, 2019
- Decision date
- March 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEW – Implantable Transprostatic Tissue Retractor System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5530
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Other 510(k)s with product code PEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232558 | UroLift 2 ATC Advanced Tissue Control SystemPEW · Special | Neotract, Inc. | 09/22/2023SE |
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgePEW · Special | Neotract, Inc. | 07/31/2020SE |
| K200441 | UroLift Advanced Tissue Control (ATC) SystemPEW · Traditional | Neotract, Inc. | 06/05/2020SE |
| K193269 | UroLift System (UL400)PEW · Special | Neotract, Inc. | 12/20/2019SE |
| K173087 | UroLift System (UL400 and UL500)PEW · Traditional | Neotract, Inc. | 12/28/2017SE |
| K172359 | UroLift System (UL500)PEW · Special | Neotract, Inc. | 08/18/2017SE |
| K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgePEW · Special | Neotract, Inc. | 09/21/2016SE |
| K153584 | NeoTract UroLift System UL500PEW · Traditional | Neotract, Inc. | 03/15/2016SE |
| K133281 | Neotract Urolift SystemPEW · Special | Neotract, Inc. | 12/20/2013SE |
More from Neotract, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232558 | UroLift 2 ATC Advanced Tissue Control SystemPEW · Special | 09/22/2023SE |
| K212396 | UroLift System Rigid Retrieval Kit Sterilization TrayKCT · Special | 10/22/2021SE |
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgePEW · Special | 07/31/2020SE |
| K200441 | UroLift Advanced Tissue Control (ATC) SystemPEW · Traditional | 06/05/2020SE |
| K192781 | UroLift System Procedure Kit Sterilization TrayKCT · Traditional | 04/14/2020SE |
| K193269 | UroLift System (UL400)PEW · Special | 12/20/2019SE |
| K173087 | UroLift System (UL400 and UL500)PEW · Traditional | 12/28/2017SE |
| K172359 | UroLift System (UL500)PEW · Special | 08/18/2017SE |
| K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgePEW · Special | 09/21/2016SE |
| K153584 | NeoTract UroLift System UL500PEW · Traditional | 03/15/2016SE |
Questions and answers
When was UroLift System UL400 cleared by the FDA?
UroLift System UL400 (K190377) received a 510(k) decision of Substantially Equivalent on March 21, 2019, 30 days after the submission was received.
What is the product code of K190377?
The FDA product code is PEW – Implantable Transprostatic Tissue Retractor System, a Class II (moderate risk) device regulated under 21 CFR 876.5530.