The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Single Use Electrosurgical Knife.
| Device ID | K193601 |
| 510k Number | K193601 |
| Device Name: | Single Use Electrosurgical Knife |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road Nanjing, CN 210032 |
| Contact | Sally He |
| Correspondent | Sally He Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road 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 | 2019-12-23 |
| Decision Date | 2020-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503555224 | K193601 | 000 |
| 16932503555101 | K193601 | 000 |
| 16932503555095 | K193601 | 000 |
| 16932503555088 | K193601 | 000 |
| 16932503555071 | K193601 | 000 |
| 16932503555064 | K193601 | 000 |
| 16932503555057 | K193601 | 000 |
| 16932503555040 | K193601 | 000 |
| 16932503555033 | K193601 | 000 |
| 16932503555026 | K193601 | 000 |
| 16932503555118 | K193601 | 000 |
| 16932503555125 | K193601 | 000 |
| 16932503555217 | K193601 | 000 |
| 16932503555200 | K193601 | 000 |
| 16932503555194 | K193601 | 000 |
| 16932503555187 | K193601 | 000 |
| 16932503555170 | K193601 | 000 |
| 16932503555163 | K193601 | 000 |
| 16932503555156 | K193601 | 000 |
| 16932503555149 | K193601 | 000 |
| 16932503555132 | K193601 | 000 |
| 16932503555019 | K193601 | 000 |