The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Looking Glass 4k Integrated Visualization System.
| Device ID | K201593 |
| 510k Number | K201593 |
| Device Name: | Looking Glass 4K Integrated Visualization System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
| Contact | Kavita Amin |
| Correspondent | Kavita Amin ConMed Corporation 525 French Road Utica, NY 13502 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-12 |
| Decision Date | 2020-07-08 |