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510(k) K230748

Disposable Ureteral Access Sheath by Youcare Technology Co.,Ltd. (Wuhan) — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2023
Date Received
March 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

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

  • K222705 — Introducer Needle (May 22, 2023)

Other clearances for product code FED

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  • K250128 — Single Use Suction-Evacuation Ureteral Access Sheath (September 19, 2025)
  • K250132 — Ureteral Access Sheath (September 5, 2025)
  • K250695 — Single-use Ureteral Access Sheath (July 8, 2025)
  • K251599 — Single-use Ureteral Access Sheath (July 3, 2025)
  • K250585 — LumenaTM Ureteral Access Sheath (June 27, 2025)
  • K250452 — CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0 (June 2, 2025)
  • K243710 — Disposable ureteral access sheath (April 11, 2025)
  • K250517 — Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator (March 21, 2025)
  • K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I (January 31, 2025)