AQ HYDROPHILIC DILATORS— 510(k) K961904

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K961904 for AQ HYDROPHILIC DILATORS, Substantially Equivalent on 1996-10-18. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-16
Decision date: 1996-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOE

K191061 — Optilume Basic Urological Balloon Dilation Catheter2020-01-02
K032840 — ATRION MEDICAL QL INFLATION DEVICE2004-03-03
K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE1997-10-10
K962611 — BARD EAGLE INFLATION DEVICE1996-10-21
K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE1993-05-26

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.