The following data is part of a premarket notification filed by Xodus Medical, Inc. with the FDA for Scope Antifogging System.
| Device ID | K182080 |
| 510k Number | K182080 |
| Device Name: | Scope Antifogging System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Xodus Medical, Inc. 702 Prominence Drive New Kensington, PA 15068 |
| Contact | Paul Lloyd |
| Correspondent | Paul Lloyd Xodus Medical, Inc. 702 Prominence Drive New Kensington, PA 15068 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2018-09-19 |
| Summary: | summary |