Company ยท CN
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ODC | Endoscope Channel Accessory | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 |
| FDI | Snare, Flexible | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 2026 | K260512 | Disposable Ureteral Access Sheath Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | FED |
| May 28, 2026 | K260423 | Disposable Endoscopic Distal Attachments Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | FDF |
| Jun 20, 2025 | K250732 | Disposable Endoscopy Valve Set Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | ODC |
| Jul 31, 2023 | K230004 | Disposable Hemoclip Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | PKL |
| Nov 21, 2022 | K222980 | Pentax Medical Valve Set Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | ODC |
| Sep 27, 2022 | K220785 | Clean Connecting Tube Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | OCX |
| Aug 19, 2022 | K220292 | Disposable Endoscope Injection Needle Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | FBK |
| Jun 27, 2022 | K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | FDI |
| Jun 17, 2022 | K220210 | Disposable Endoscopy Adapter Set Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | ODC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||