K232558
- 510(k) number
- K232558
- Device name
- UroLift 2 ATC Advanced Tissue Control System
- Applicant
- Neotract, Inc. CA · US
- Product code
- PEW — Implantable Transprostatic Tissue Retractor System
- Decision date
- 2023-09-22
- Date received
- 2023-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K232558.pdf
Official FDA record: K232558
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.