The following data is part of a premarket notification filed by Stryker with the FDA for 1688 4k Camera Control Unit With Advanced Imaging Modality (1688010000), 1688 4k Pendulum Camera Head (1688310130).
| Device ID | K220895 |
| 510k Number | K220895 |
| Device Name: | 1688 4K Camera Control Unit With Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | Marlene Fraga |
| Correspondent | Marlene Fraga Stryker 5900 Optical Court 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 | 2022-03-28 |
| Decision Date | 2022-04-22 |