Home / 510(k) Clearances / K232529

510(k) K232529

Disposable Double Lumen Endobronchial Tube by Shenzhen Insighters Medical Technology Co., Ltd. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2024
Date Received
August 21, 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

Other clearances by Shenzhen Insighters Medical Technology Co., Ltd.

  • K242793 — Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; In (May 28, 2025)
  • K232580 — Disposable Endobronchial Blocker Tube (December 14, 2023)

Other clearances for product code CBI

  • K253096 — Chartis Precision Catheter (February 13, 2026)
  • K232580 — Disposable Endobronchial Blocker Tube (December 14, 2023)
  • K222340 — Chartis Precision Catheter (December 1, 2022)
  • K201026 — sOLVe Tube (August 10, 2021)
  • K203749 — Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (May 3, 2021)
  • K200968 — ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (December 28, 2020)
  • K181886 — VivaSight-DL System (November 14, 2018)
  • K180253 — Sheridan Endobronchial Tubes (November 2, 2018)
  • K160542 — 5.0 Fr Arndt Endobronchial Blocker Set (August 2, 2016)
  • K152251 — Endobronchial Tube (June 10, 2016)