The following data is part of a premarket notification filed by Partnership Medical Limited with the FDA for Scopeflow Pure(tm).
| Device ID | K181418 |
| 510k Number | K181418 |
| Device Name: | ScopeFlow Pure(TM) |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Partnership Medical Limited Hartley House, Galveston Grove Fenton, GB St43pe |
| Contact | Rob Hartley |
| Correspondent | Silbiano Gonzales QRC Consulting, LLC 10422 Huebner Road, Apt# 508 San Antonio, TX 78240 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-31 |
| Decision Date | 2019-07-11 |