The following data is part of a premarket notification filed by Stryker with the FDA for 1688 Pendulum 4k Camera Head With Integrated Coupler, 1688 4k Camera Control Unit With Advanced Imaging Modality.
| Device ID | K200310 |
| 510k Number | K200310 |
| Device Name: | 1688 Pendulum 4K Camera Head With Integrated Coupler, 1688 4K Camera Control Unit With Advanced Imaging Modality |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Ct San Jose, CA 95138 |
| Contact | April Malmborg |
| Correspondent | April Malmborg 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 | 2020-02-06 |
| Decision Date | 2020-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327501995 | K200310 | 000 |