COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH— 510(k) K072521

Name: FDA 510(k) clearance K072521
Creator: U.S. Food and Drug Administration
Published: 2007-11-20

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K072521 for COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH, Substantially Equivalent on 2007-11-20. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FFS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2007-09-07
Decision date: 2007-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER2008-11-07
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Recalls naming K072521

K-number listed on FDA's recall record

Z-2540-2017 — Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packagesClass II·Terminated·Cook Inc.·20170503

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072521.

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