The following data is part of a premarket notification filed by Ga Health Company Limited with the FDA for Andorate Universal Endoscope Tip Guard.
| Device ID | K202838 |
| 510k Number | K202838 |
| Device Name: | Andorate Universal Endoscope Tip Guard |
| Classification | Endoscopic Storage Cover |
| Applicant | GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN |
| Contact | Cindy Ye |
| Correspondent | Cindy Ye GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN |
| Product Code | OCU |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2021-03-05 |