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510(k) K232558

UroLift 2 ATC Advanced Tissue Control System by Neotract, Inc. — Product Code PEW

K232558 is an FDA 510(k) premarket notification submitted by Neotract, Inc. for the device "UroLift 2 ATC Advanced Tissue Control System". The FDA issued a decision of Substantially Equivalent on September 22, 2023. The device falls under product code PEW (Implantable Transprostatic Tissue Retractor System), a Class II device regulated under 21 CFR 876.5530. Neotract, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2023
Date Received
August 23, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Transprostatic Tissue Retractor System
Device Class
Class II
Regulation Number
876.5530
Review Panel
GU
Submission Type

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

Other clearances by Neotract, Inc.

  • K212396 — UroLift System Rigid Retrieval Kit Sterilization Tray (October 22, 2021)
  • K201837 — UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant (July 31, 2020)
  • K200441 — UroLift Advanced Tissue Control (ATC) System (June 5, 2020)
  • K192781 — UroLift System Procedure Kit Sterilization Tray (April 14, 2020)
  • K193269 — UroLift System (UL400) (December 20, 2019)
  • K190377 — UroLift System UL400 (March 21, 2019)
  • K173087 — UroLift System (UL400 and UL500) (December 28, 2017)
  • K172359 — UroLift System (UL500) (August 18, 2017)
  • K162345 — UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (September 21, 2016)
  • K153584 — NeoTract UroLift System UL500 (March 15, 2016)

Other clearances for product code PEW

  • K201837 — UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant (July 31, 2020)
  • K200441 — UroLift Advanced Tissue Control (ATC) System (June 5, 2020)
  • K193269 — UroLift System (UL400) (December 20, 2019)
  • K190377 — UroLift System UL400 (March 21, 2019)
  • K173087 — UroLift System (UL400 and UL500) (December 28, 2017)
  • K172359 — UroLift System (UL500) (August 18, 2017)
  • K162345 — UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (September 21, 2016)
  • K153584 — NeoTract UroLift System UL500 (March 15, 2016)
  • K133281 — NEOTRACT UROLIFT SYSTEM (December 20, 2013)
  • DEN130023 — UROLIFT SYSTEM (September 13, 2013)

FDA data resources