The following data is part of a premarket notification filed by Stryker with the FDA for 1688 Camera Control Unit ; 1688 Aim 4k Camera Head, C-mount ; 1688 Aim 4k Camera Head With Integrated Coupler ; Aim 4k Coupler, 20mm, C-mount ; L11 Led Light Source With Aim.
| Device ID | K182160 |
| 510k Number | K182160 |
| Device Name: | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head With Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source With AIM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | April Malmborg |
| Correspondent | April Malmborg Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | GCJ |
| Subsequent Product Code | FCS |
| Subsequent Product Code | FCW |
| Subsequent Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-08-09 |
| Decision Date | 2018-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327455915 | K182160 | 000 |
| 07613327420081 | K182160 | 000 |
| 07613327418996 | K182160 | 000 |
| 07613327418989 | K182160 | 000 |
| 07613327382389 | K182160 | 000 |
| 07613327419009 | K182160 | 000 |