The following data is part of a premarket notification filed by Ga Health Company Limited with the FDA for Andorate Biopsy Valve, Andorate Biopsy Irrigator.
| Device ID | K200481 |
| 510k Number | K200481 |
| Device Name: | Andorate Biopsy Valve, Andorate Biopsy Irrigator |
| Classification | Endoscope Channel Accessory |
| Applicant | GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN |
| Contact | Cindy Ye |
| Correspondent | Rafael Aguila Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155 -3708 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-02-27 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816734022983 | K200481 | 000 |