The following data is part of a premarket notification filed by Anrei Medical (hangzhou) Co., Ltd. with the FDA for Multi-functional Electrosurgical Knife.
| Device ID | K212999 |
| 510k Number | K212999 |
| Device Name: | Multi-Functional Electrosurgical Knife |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Anrei Medical (Hangzhou) Co., Ltd. No. 3 Ave 8, HEDA Hangzhou, CN 310018 |
| Contact | Huibing Yang |
| Correspondent | Huibing Yang Anrei Medical (Hangzhou) Co., Ltd. No. 3 Ave 8, HEDA Hangzhou, CN 310018 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06948318946785 | K212999 | 000 |
| 06948318946778 | K212999 | 000 |