Atlas FDA

Disposable Ureteral Stents

FDA 510(k) clearance K251890 · decided 2026-02-20

Clearance details

K-number
K251890
Device name
Disposable Ureteral Stents
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Decision
Substantially Equivalent
Date received
2025-06-20
Decision date
2026-02-20
Days to decision
245 days
Clearance type
Traditional
Product code
FAD
Device class
2
Regulation number
876.4620
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hangzhou, CN
Third-party review
No
Expedited review
No

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ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits (K213185)Coloplast Corp.2022-06-08
RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (K213444)Ureteral Stent Company2022-03-17
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JFil Ureteral Stents, JFil Ureteral Stents ECO KIT (K212868)Rocamed Sam2022-01-26
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Recalls involving this device

No recalls on record reference this clearance.