URODYNAMIC CATHETER— 510(k) K915443

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K915443 for URODYNAMIC CATHETER, Substantially Equivalent on 1992-02-19. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1991-12-05
Decision date: 1992-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAP

K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE2012-12-13
K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE1998-02-19
K963330 — URODYNAMIC ANALYSIS MODULE1997-04-03
K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER1996-08-27
K931175 — SCHUSTER DISPOSABLE BALLOON PROBE1994-04-01

More clearances from Cook Urological, Inc.

K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)2011-05-06
K091767 — 3 WAY SILICONE FOLEY BALLOON CATHETER2009-10-09
K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-1224002009-09-03
K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER2008-11-07
K082536 — COOK WIRE GUIDES2008-10-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.