The following data is part of a premarket notification filed by Yangzhou Fartley Medical Instrument Technology Co., Ltd. with the FDA for Disposable Endoscope Injection Needle.
| Device ID | K220292 |
| 510k Number | K220292 |
| Device Name: | Disposable Endoscope Injection Needle |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | Yangzhou Fartley Medical Instrument Technology Co., Ltd. Beizhou Road, Lidian Town, Guangling District Yangzhou, CN 225106 |
| Contact | Tina Han |
| Correspondent | Ethan Liu Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, CN 201100 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-01 |
| Decision Date | 2022-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936603226568 | K220292 | 000 |
| 06936603226551 | K220292 | 000 |
| 06936603226544 | K220292 | 000 |