The following data is part of a premarket notification filed by Smith And Nephew, Inc. with the FDA for Smith & Nephew Intellio 4k Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4k Camera Control Unit, Non-network Enabled (72205448).
| Device ID | K221740 |
| 510k Number | K221740 |
| Device Name: | SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Smith And Nephew, Inc. 150 Minuteman Road Andover, MA 01810 |
| Contact | Renesha Srivastava |
| Correspondent | Renesha Srivastava 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 | 2022-06-15 |
| Decision Date | 2022-10-20 |