510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190377Substantially Equivalent

UroLift System UL400

Neotract Inc, Pleasanton CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190377 is the FDA 510(k) clearance record for UroLift System UL400, a class II device, cleared for Neotract, Inc. on under FDA product code PEW (Implantable Transprostatic Tissue Retractor System). FDA's definition for product code PEW reads: "The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above". FDA records list 17 510(k) clearances for Neotract, Inc., from to . As of , FDA records show no recalls naming K190377.

Clearance record

Decision date
Received
(30 days to decision)
Product code
PEW Implantable Transprostatic Tissue Retractor System
Regulation
21 CFR 876.5530
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Neotract, Inc. 4473 Willow Rd., Suite 100, Pleasanton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEW

Trailing 12 months

FDA records hold no clearances under product code PEW in the trailing twelve months.

FDA records show no clearances under product code PEW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PEW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260