510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K855176Substantially Equivalent

Transurethal Prostatome Diag Treatm Propulsion Sys

Urologic Surgical Devices Corp., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855176 is the FDA 510(k) clearance record for TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS, a class II device, cleared for Urologic Surgical Devices Corp. on under FDA product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology). FDA's definition for product code FBK reads: "inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue". FDA records list one 510(k) clearance for Urologic Surgical Devices Corp. As of , FDA records show no recalls naming K855176.

Clearance record

Decision date
Received
(138 days to decision)
Product code
FBK Endoscopic Injection Needle, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Urologic Surgical Devices Corp. 343 S. Dearborn St., Chicago IL
Third party review
No

Clearances, product code FBK

Trailing 12 months
3 clearances under product code FBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260