510(k) K232580
K232580 is an FDA 510(k) premarket notification submitted by Shenzhen Insighters Medical Technology Co., Ltd. for the device "Disposable Endobronchial Blocker Tube". The FDA issued a decision of Substantially Equivalent on December 14, 2023. The device falls under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5740. Shenzhen Insighters Medical Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2023
- Date Received
- August 25, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5740
- Review Panel
- AN
- Submission Type