The following data is part of a premarket notification filed by Pristine Surgical with the FDA for Pristine Scope.
| Device ID | K183165 |
| 510k Number | K183165 |
| Device Name: | Pristine Scope |
| Classification | Arthroscope |
| Applicant | Pristine Surgical Brady Sullivan Tower, 6th Floor, 1750 Elm Street Manchester, NH 03104 |
| Contact | Stewart B. Davis |
| Correspondent | Stewart B. Davis Pristine Surgical Brady Sullivan Tower, 6th Floor, 1750 Elm Street Manchester, NH 03104 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-15 |
| Decision Date | 2019-01-16 |