The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Ensure Single-use Coagulation Forceps.
| Device ID | K202438 |
| 510k Number | K202438 |
| Device Name: | Ensure Single-Use Coagulation Forceps |
| Classification | Forceps, Biopsy, Electric |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Thrid Road Nanjing, CN 210032 |
| Contact | Cecilia Sun |
| Correspondent | Cecilia Sun Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road Nanjing, CN 210032 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-25 |
| Decision Date | 2021-03-15 |
| Summary: | summary |