K232580 is an FDA 510(k) clearance for the Disposable Endobronchial Blocker Tube. This device is classified as a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II - Special Controls, product code CBI).
Submitted by Shenzhen Insighters Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 14, 2023, 111 days after receiving the submission on August 25, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5740.
| 510(k) Number | K232580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2023 |
| Decision Date | December 14, 2023 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBI - Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5740 |