Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.: 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd. Its amount of 216 is above the median of 138 (70th percentile). Dated 45 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 216 · 70th percentile of 414 FDAPulse records · 1.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260512 |
| Device | Disposable Ureteral Access Sheath |
| Applicant | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | FED |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-17 |
| Decision date | 2026-09-21 |
| Review time (days) | 216 |
| Third-party review | No |
| Applicant location | Yangzhou, CN |
| amount percentile | 70th of 414 (median 138, 1.6x median) |
| Peer records CSV (76 CN records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.'s amount: 70th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 216-day review, longer than typical.
- Posted 45 days ago.
What is the FDAPulse record for Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.?
Disposable Ureteral Access Sheath (K260512) by Yangzhou Fartley Medical Instrument Technology Co., Ltd. was cleared on 2026-09-21 after 216 days of review.
How does Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd. compare to other FDAPulse records?
Its amount of 216 sits in the upper half (70th percentile) of 414 records; the median is 138. It is 45 days old, still within a typical 45-day follow-up window.
Disposable Ureteral Access Sheath (K260512) vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| Disposable Ureteral Access Sheath (K260512) | CN | 2026-09-21 | This record |
| Drainage Catheter (K254179) | CN | 2026-09-18 | View record → |
| Single Use Ureteral Access Sheath (K260410) | CN | 2026-09-11 | Compare Disposable Ureteral Access Sheath (K260512) vs Single Use Ureteral Access Sheath (K260410) → |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Gastroenterology & Urology devices
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