K211894 is an FDA 510(k) clearance for the Trachealator. This device is classified as a Bronchoscope Accessory (Class II - Special Controls, product code KTI).
Submitted by Disa Medinotec (Johannesburg, ZA). The FDA issued a Cleared decision on November 24, 2021, 156 days after receiving the submission on June 21, 2021.
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 | K211894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2021 |
| Decision Date | November 24, 2021 |
| Days to Decision | 156 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). |