Introducer Needle

FDA 510(k) K222705 · Youcare Technology Co.,Ltd. (Wuhan)

Substantially Equivalent

510(k) numberK222705

Submission

Device name
Introducer Needle
Applicant
Youcare Technology Co.,Ltd. (Wuhan)
Wuhan, CN
Received
September 7, 2022
Decision date
May 22, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LJE – Catheter, Nephrostomy
Device class
Unclassified

Other 510(k)s with product code LJE

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K250448Disposable Percutaneous Nephrostomy Dilatation KitLJE · Traditional Shenzhen Trious Medical Technology Co., Ltd.07/03/2025SE
K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits…LJE · Traditional Coloplast Corp.03/10/2022SESK
K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathLJE · Traditional Coloplast Corp.12/17/2020SESK
K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional Cook Incorporated01/29/2020SESK
K190903Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional Cook Incorporated12/16/2019SE
K183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetLJE · Traditional Cook Incorporated07/16/2019SESK
K183035Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar NeedleLJE · Traditional Cook Incorporated05/17/2019SESK
K181735Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetLJE · Traditional Cook Incorporated03/27/2019SESK
K181713Ultraxx Nephrostomy Balloon Catheter SetLJE · Traditional Cook Incorporated08/17/2018SE
K171601Ultraxx Nephrostomy Balloon CatheterLJE · Traditional Cook Incorporated02/23/2018SE

More from Cook Incorporated

510(k)DeviceDecision
K230748Disposable Ureteral Access SheathFED · Traditional 08/02/2023SE

Questions and answers

When was Introducer Needle cleared by the FDA?

Introducer Needle (K222705) received a 510(k) decision of Substantially Equivalent on May 22, 2023, 257 days after the submission was received.

What is the product code of K222705?

The FDA product code is LJE – Catheter, Nephrostomy, a Unclassified device.