INSEMI-CATH II— 510(k) K954398

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K954398 for INSEMI-CATH II, Substantially Equivalent on 1995-12-19. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code MFD
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 1995-09-20
Decision date: 1995-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MFD

K021438 — INSEMINATION CATHETER, MODEL 3203012002-07-16
K012935 — THECURVE, ITEM 5072001-10-11
K984306 — `THE INSEMINATOR' (PROPOSED)1999-03-01
K982630 — MEDWORKS VISUALIZATION INSEMINATION CATHETER1999-01-14
K982628 — MEDWORKS INSEMINATION CATHETER1998-08-21

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.