Home / 510(k) Clearances / K250585

510(k) K250585

LumenaTM Ureteral Access Sheath by Cathegenix (Xiamen) Co., Ltd. — Product Code FED

K250585 is an FDA 510(k) premarket notification submitted by Cathegenix (Xiamen) Co., Ltd. for the device "LumenaTM Ureteral Access Sheath". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Cathegenix (Xiamen) Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2025
Date Received
February 27, 2025
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 Cathegenix (Xiamen) Co., Ltd.

  • K251469 — Endura™ Ureteral Stent and Stent Set (December 19, 2025)

Other clearances for product code FED

  • K260965 — CVAC Aspiration System (April 13, 2026)
  • K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100- (April 6, 2026)
  • 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)
  • 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)

FDA data resources