ILLUMINATED URETERAL CATHETER— 510(k) K923436

Name: FDA 510(k) clearance K923436
Creator: U.S. Food and Drug Administration
Published: 1993-03-05

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K923436 for ILLUMINATED URETERAL CATHETER, Substantially Equivalent on 1993-03-05. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FCS
Device class: Class 2
Regulation: 21 CFR 876.4020
Advisory panel: Gastroenterology, Urology
Date received: 1992-07-13
Decision date: 1993-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K923436

K-number listed on FDA's recall record

Z-1870-2017 — Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter SetClass II·Terminated·Cook Inc.·20170307

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K923436.

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