K230280 is an FDA 510(k) clearance for the ANDORATE? Suction Valve and ANDORATE? Biopsy Valve. This device is classified as a Bronchoscope Accessory (Class II - Special Controls, product code KTI).
Submitted by Ga Health Company Limited (Hong Kong, HK). The FDA issued a Cleared decision on May 11, 2023, 99 days after receiving the submission on February 1, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K230280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2023 |
| Decision Date | May 11, 2023 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KTI — Bronchoscope Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |