The following data is part of a premarket notification filed by Saneso Inc. with the FDA for Saneso Colonoscope 360-a (model: With/without Select Band Imaging (sbi) And With/without Dual Band Imaging(dbi)), Saneso Single Camera Colonoscope-a (model: With/without Select Band Imaging (sbi)), Saneso Gastroscope 360-a (model: With/without Select.
| Device ID | K210052 |
| 510k Number | K210052 |
| Device Name: | Saneso Colonoscope 360-A (Model: With/without Select Band Imaging (SBI) And With/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: With/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: With/without Select |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Saneso Inc. One Oxford Center, 301 Grant Street Suite 4300 Pittsburgh, PA 15219 |
| Contact | Nitesh Ratnakar |
| Correspondent | Parul Chansoria Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan, WY 82801 |
| Product Code | FDF |
| Subsequent Product Code | FDS |
| Subsequent Product Code | FET |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-08 |
| Decision Date | 2022-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G347SAN360GA0 | K210052 | 000 |
| G347SAN360CA0 | K210052 | 000 |
| G347SBA0 | K210052 | 000 |
| G347SAN1GA0 | K210052 | 000 |
| G347SAN1CA0 | K210052 | 000 |