VPI NON-ADHESIVE CONDOM CATHETER— 510(k) K883119

Name: FDA 510(k) clearance K883119
Creator: U.S. Food and Drug Administration
Published: 1988-08-02

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K883119 for VPI NON-ADHESIVE CONDOM CATHETER, Substantially Equivalent on 1988-08-02. Applicant: Cook Urological, Inc.. Device class: 1.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code EYT
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1988-07-25
Decision date: 1988-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EYT

view all

K934080 — URINARY DRAINAGE BAG1994-05-18
K935774 — CURITY FAST-CATH FEMALE CATHETER KIT1994-04-11
K883057 — COMFORT CATH MALE EXTERNAL CATHETER1988-08-02

More clearances from Cook Urological, Inc.

view all

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.