The following data is part of a premarket notification filed by Smith And Nephew, Inc. with the FDA for Lens 4k Camera Control Unit - Wifi, Lens 4k Camera Control Unit - Non-wifi, Lens 4k Camera Head.
| Device ID | K191177 |
| 510k Number | K191177 |
| Device Name: | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Smith And Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Contact | Kathleen Solomon |
| Correspondent | Kathleen Solomon Smith And Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-02 |
| Decision Date | 2019-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556765807 | K191177 | 000 |
| 00885556731208 | K191177 | 000 |
| 00885556731192 | K191177 | 000 |
| 00885556731185 | K191177 | 000 |
| 00885556731178 | K191177 | 000 |
| 00885556731161 | K191177 | 000 |
| 00885556731154 | K191177 | 000 |
| 00885556731147 | K191177 | 000 |
| 00885556731130 | K191177 | 000 |
| 00885556730980 | K191177 | 000 |
| 00885556730966 | K191177 | 000 |
| 00885556730706 | K191177 | 000 |
| 00885556730928 | K191177 | 000 |
| 00885556730898 | K191177 | 000 |
| 00885556757031 | K191177 | 000 |
| 00885556757024 | K191177 | 000 |
| 00885556731215 | K191177 | 000 |
| 00885556731222 | K191177 | 000 |
| 00885556730959 | K191177 | 000 |
| 00885556730942 | K191177 | 000 |
| 00885556730935 | K191177 | 000 |
| 00885556730911 | K191177 | 000 |
| 00885556730904 | K191177 | 000 |
| 00885556730881 | K191177 | 000 |
| 00885556730874 | K191177 | 000 |
| 00885556730867 | K191177 | 000 |
| 00885556730850 | K191177 | 000 |
| 00885556720844 | K191177 | 000 |
| 00885556720790 | K191177 | 000 |
| 00885556765791 | K191177 | 000 |
| 00885556731260 | K191177 | 000 |
| 00885556731246 | K191177 | 000 |
| 00885556731239 | K191177 | 000 |
| 00885556757017 | K191177 | 000 |