The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Single Use Electrosurgical Knife With Fluid Pump System.
| Device ID | K211172 |
| 510k Number | K211172 |
| Device Name: | Single Use Electrosurgical Knife With Fluid Pump System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing, CN 210032 |
| Contact | Sally He |
| Correspondent | Becky Li Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing, CN 210032 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-19 |
| Decision Date | 2021-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26932503571030 | K211172 | 000 |
| 26932503571023 | K211172 | 000 |
| 26932503571016 | K211172 | 000 |
| 16932503571064 | K211172 | 000 |
| 16932503571057 | K211172 | 000 |
| 16932503571040 | K211172 | 000 |