URETHRAL BALLOON DILATION CATHETER SET— 510(k) K892855

Name: FDA 510(k) clearance K892855
Creator: U.S. Food and Drug Administration
Published: 1989-11-17

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K892855 for URETHRAL BALLOON DILATION CATHETER SET, Substantially Equivalent on 1989-11-17. 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: 1989-04-18
Decision date: 1989-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOE

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K962611 — BARD EAGLE INFLATION DEVICE1996-10-21
K961904 — AQ HYDROPHILIC DILATORS1996-10-18

More clearances from Cook Urological, Inc.

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K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-1224002009-09-03
K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER2008-11-07
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Recalls naming K892855

K-number listed on FDA's recall record

Z-0970-2020 — Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844Class II·Terminated·Cook Inc.·20190104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K892855.

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