The following data is part of a premarket notification filed by Yangzhou Fartley Medical Instrument Technology Co., Ltd. with the FDA for Disposable Endoscopy Adapter Set.
| Device ID | K220210 |
| 510k Number | K220210 |
| Device Name: | Disposable Endoscopy Adapter Set |
| Classification | Endoscope Channel Accessory |
| 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 | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-26 |
| Decision Date | 2022-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970900850934 | K220210 | 000 |
| 06936603225615 | K220210 | 000 |
| 06936603225592 | K220210 | 000 |
| 06936603225585 | K220210 | 000 |
| 06936603225578 | K220210 | 000 |
| 06936603225561 | K220210 | 000 |
| 06936603225554 | K220210 | 000 |
| 06936603224410 | K220210 | 000 |
| 06936603224403 | K220210 | 000 |
| 06936603216491 | K220210 | 000 |
| 06936603216477 | K220210 | 000 |
| 06936603216460 | K220210 | 000 |
| 06936603225622 | K220210 | 000 |
| 06936603225639 | K220210 | 000 |
| 06936603217146 | K220210 | 000 |
| 06936603217139 | K220210 | 000 |
| 06936603217085 | K220210 | 000 |
| 06936603217061 | K220210 | 000 |
| 06936603217009 | K220210 | 000 |
| 06936603216897 | K220210 | 000 |
| 06936603216866 | K220210 | 000 |
| 06936603216842 | K220210 | 000 |
| 06936603216781 | K220210 | 000 |
| 06936603209516 | K220210 | 000 |
| 06936603225646 | K220210 | 000 |
| 06936603210567 | K220210 | 000 |