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Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd. vs Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.: FDAPulse comparison
Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.'s review days of 216 is 1.0x Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd.'s 214 (70th percentile). Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd. is dated 2026-09-11; Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd. 2026-09-21.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd. compare to Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.?
| Field | Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd. | Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K260410 | K260512 |
| Device | Single Use Ureteral Access Sheath | Disposable Ureteral Access Sheath |
| Applicant | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
| Specialty / panel | Gastroenterology, Urology | Gastroenterology, Urology |
| Product code | FED | FED |
| Device class | 2 | 2 |
| Clearance type | Special | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-02-09 | 2026-02-17 |
| Decision date | 2026-09-11 | 2026-09-21 |
| Review time (days) | 214 | 216 |
| Third-party review | No | No |
| Applicant location | Hangzhou, CN | Yangzhou, CN |
| amount percentile | 69th | 70th |
| Predicate Speed & CAPA Advisory Opportunity Score | 47/100 | 48/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd. · Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.
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