The following data is part of a premarket notification filed by Pristine Surgical with the FDA for Pristine Scope.
| Device ID | K193161 |
| 510k Number | K193161 |
| Device Name: | Pristine Scope |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-15 |
| Decision Date | 2020-04-21 |