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510(k) K251599

Single-use Ureteral Access Sheath by Hunan Vathin Medical Instrument Co., Ltd. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
May 27, 2025
Clearance Type
Special
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 Hunan Vathin Medical Instrument Co., Ltd.

  • K250232 — Vathin® Video Bronchoscope System (July 25, 2025)
  • K250785 — Single-use Flexible Ureteroscope (May 6, 2025)
  • K243117 — Digital Video Processor (January 29, 2025)
  • K242416 — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E (January 16, 2025)
  • K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G (December 18, 2024)
  • K241612 — Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H0 (October 29, 2024)
  • K240167 — Single-use Ureteral Access Sheath (October 8, 2024)
  • K241434 — Video Ureteroscope System (October 4, 2024)
  • K231135 — Video Ureteroscope System (January 17, 2024)
  • K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (June 14, 2023)

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)
  • 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)
  • K243025 — Ureteral Access Sheath (January 30, 2025)