The following data is part of a premarket notification filed by Stryker with the FDA for Sdc3 Hd Information Management System With Wireless Device Control Capability.
| Device ID | K210584 |
| 510k Number | K210584 |
| Device Name: | SDC3 HD Information Management System With Wireless Device Control Capability |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Ct San Jose, CA 95138 |
| Contact | Divya Sekar |
| Correspondent | Divya Sekar Stryker 5900 Optical Ct San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-03-18 |