510(k) K190377
K190377 is an FDA 510(k) premarket notification submitted by Neotract, Inc. for the device "UroLift System UL400". The FDA issued a decision of Substantially Equivalent on March 21, 2019. 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
- March 21, 2019
- Date Received
- February 19, 2019
- 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.