The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Lens Camera Control Unit-wifi, Lens Camera Unit-non-wifi, Lens Camera Head, Camera Coupler, Tablet Application.
| Device ID | K153606 |
| 510k Number | K153606 |
| Device Name: | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS Camera Head, Camera Coupler, Tablet Application |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SMITH & NEPHEW 150 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW 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 | 2015-12-17 |
| Decision Date | 2016-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556653876 | K153606 | 000 |
| 00885556618097 | K153606 | 000 |
| 00885556618080 | K153606 | 000 |
| 00885556618073 | K153606 | 000 |
| 00885556618066 | K153606 | 000 |
| 00885556618059 | K153606 | 000 |
| 00885556618042 | K153606 | 000 |
| 00885556618035 | K153606 | 000 |
| 00885556617915 | K153606 | 000 |
| 00885556617908 | K153606 | 000 |
| 00885556617878 | K153606 | 000 |
| 00885556618103 | K153606 | 000 |
| 00885556618110 | K153606 | 000 |
| 00885556651421 | K153606 | 000 |
| 00885556632048 | K153606 | 000 |
| 00885556632024 | K153606 | 000 |
| 00885556632000 | K153606 | 000 |
| 00885556631980 | K153606 | 000 |
| 00885556629833 | K153606 | 000 |
| 00885556624906 | K153606 | 000 |
| 00885556618158 | K153606 | 000 |
| 00885556618141 | K153606 | 000 |
| 00885556618127 | K153606 | 000 |
| 00885556616727 | K153606 | 000 |