FDA.reportPublic FDA data

510(k) K191498

Device
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
Applicant
Cook Incorporated
510(k) number
K191498
Product code
LJE
Decision
Unknown (SESK)
Decision date
2020-01-29
Date received
2019-06-05
Classification name
Catheter, Nephrostomy
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carly Powell
Address
750 Daniels Way Bloomington IN US 47404 47404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K160077RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture SetJbw7 Innovations, LLC2016-07-12
K132383GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETERGyrus Acmi, Inc.2014-02-04
K121614NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETERBoston Scientific Corp2012-09-18