The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Connected Or Hub With Device And Voice Control.
| Device ID | K212055 |
| 510k Number | K212055 |
| Device Name: | Connected OR Hub With Device And Voice Control |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Corporation 5900 Optical Ct San Jose, CA 95138 |
| Contact | Eugene Perelshteyn |
| Correspondent | Eugene Perelshteyn Stryker Corporation 5900 Optical Ct 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 | 2021-07-01 |
| Decision Date | 2021-12-16 |