510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901494Substantially Equivalent

Etude, Urodynamic Investigation System

Dantec Medical, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901494 is the FDA 510(k) clearance record for ETUDE, URODYNAMIC INVESTIGATION SYSTEM, a class II device, cleared for Dantec Medical, Inc. on under FDA product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device). FDA records list 25 510(k) clearances for Dantec Medical, Inc., from to . As of , FDA records show no recalls naming K901494.

Clearance record

Decision date
Received
(211 days to decision)
Product code
FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dantec Medical, Inc. 1575 Eye St. NW, Washington DC
Third party review
No

Clearances, product code FAP

Trailing 12 months

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

FDA records show no clearances under product code FAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAP, 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