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510(k) K220065

Single Use Ureteral Access Sheath by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2022
Date Received
January 10, 2022
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.

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  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)
  • K220063 — Single Use Cytology Brush (July 28, 2022)
  • K212669 — Single Use Hemoclip (May 27, 2022)
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  • K191900 — Single Use Grasping Forceps (March 27, 2020)
  • K192258 — Disposable Valve Sets (December 30, 2019)
  • K173758 — Disposable Biopsy Valve (May 14, 2018)

Other clearances for product code FED

  • K252572 — Prodeon Urethral Sheath System (October 7, 2025)
  • 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)