The following data is part of a premarket notification filed by Micro-tech (nanjing) Co.,ltd. with the FDA for Endoscopic Ultrasound Aspiration Needle.
| Device ID | K172309 |
| 510k Number | K172309 |
| Device Name: | Endoscopic Ultrasound Aspiration Needle |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | Micro-Tech (Nanjing) CO.,Ltd. No. 10 Gaoke Third Road Nanjing, CN 210032 |
| Contact | Becky Li |
| Correspondent | Becky Li Micro-Tech (Nanjing) CO.,Ltd. No. 10 Gaoke Third Road Nanjing, CN 210032 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-31 |
| Decision Date | 2017-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503534625 | K172309 | 000 |
| 16932503534618 | K172309 | 000 |
| 16932503534601 | K172309 | 000 |
| 16932503534595 | K172309 | 000 |
| 16932503534588 | K172309 | 000 |
| 16932503534571 | K172309 | 000 |
| 16932503534564 | K172309 | 000 |
| 16932503534540 | K172309 | 000 |
| 16932503534526 | K172309 | 000 |