510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K960387Substantially Equivalent

Urosprobe System, Model 1000

Uros Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960387 is the FDA 510(k) clearance record for UROSPROBE SYSTEM, MODEL 1000, a class II device, cleared for Uros Corp. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list one 510(k) clearance for Uros Corp. As of , FDA records show no recalls naming K960387.

Clearance record

Decision date
Received
(66 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Uros Corp. 1668 Los Altos Rd., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260