The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd. with the FDA for Endo Motor.
| Device ID | K203320 |
| 510k Number | K203320 |
| Device Name: | Endo Motor |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone Guilin, CN 541004 |
| Contact | Alex Wang |
| Correspondent | Giselle Zhang Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2021-05-10 |
| Summary: | summary |