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510(k) K222705

Introducer Needle by Youcare Technology Co.,Ltd. (Wuhan) — Product Code LJE

K222705 is an FDA 510(k) premarket notification submitted by Youcare Technology Co.,Ltd. (Wuhan) for the device "Introducer Needle". The FDA issued a decision of Substantially Equivalent on May 22, 2023. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Youcare Technology Co.,Ltd. (Wuhan) has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2023
Date Received
September 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Youcare Technology Co.,Ltd. (Wuhan)

  • K230748 — Disposable Ureteral Access Sheath (August 2, 2023)

Other clearances for product code LJE

  • K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit (July 3, 2025)
  • K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kit (March 10, 2022)
  • K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (December 17, 2020)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (July 16, 2019)
  • K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Tro (May 17, 2019)
  • K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (March 27, 2019)
  • K181713 — Ultraxx Nephrostomy Balloon Catheter Set (August 17, 2018)
  • K171601 — Ultraxx Nephrostomy Balloon Catheter (February 23, 2018)

FDA data resources