510(k) K222705

Device
Introducer Needle
Applicant
Youcare Technology Co.,Ltd. (Wuhan)
510(k) number
K222705
Product code
LJE
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-22
Date received
2022-09-07
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
Bing Hu
Address
Great Wall Science And Technology Park East Lake Development Zone, Wuhan Wuhan CN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LJE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated2018-08-17
K171601Ultraxx Nephrostomy Balloon CatheterCook Incorporated2018-02-23
K172929Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheathBoston Scientific Corporation2018-01-10
K172527Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque StripeCook Incorporated2017-10-19
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