The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Sdc3 Hd Information Management System With Wireless Device Control Capability.
| Device ID | K160332 |
| 510k Number | K160332 |
| Device Name: | Stryker SDC3 HD Information Management System With Wireless Device Control Capability |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 |
| Contact | Angela Wong |
| Correspondent | Angela Wong Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327311846 | K160332 | 000 |
| 07613327311839 | K160332 | 000 |
| 07613327056174 | K160332 | 000 |
| 07613327056167 | K160332 | 000 |
| 07613327056150 | K160332 | 000 |