Home / 510(k) Clearances / K230280

510(k) K230280

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve by Ga Health Company Limited — Product Code KTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2023
Date Received
February 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bronchoscope Accessory
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

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).

Other clearances by Ga Health Company Limited

  • K232118 — ANDORATE® Valve Kit (October 16, 2023)
  • K231602 — Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tub (August 1, 2023)
  • K230932 — ANDORATE® Valve Kit (July 7, 2023)
  • K223171 — AquaPulse® Irrigation Tubing (November 10, 2022)
  • K213095 — andorate Suction Valve, andorate Air/Water Valve (January 12, 2022)
  • K202838 — Andorate Universal Endoscope Tip Guard (March 5, 2021)
  • K202560 — AquaPulse Irrigation Tubing (December 10, 2020)
  • K200495 — Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve (June 24, 2020)
  • K200481 — Andorate Biopsy Valve, Andorate Biopsy Irrigator (June 18, 2020)
  • K200479 — AquaPulse Auxiliary Water Connector (May 15, 2020)

Other clearances for product code KTI

  • K254040 — LungFlow Basket Catheter (March 12, 2026)
  • K251402 — LIA-1 Catheter (542-1) (December 19, 2025)
  • K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (October 8, 2025)
  • K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA (July 29, 2025)
  • K250263 — Disposable Grasping Forceps FG-52D/FG-54D (March 31, 2025)
  • K241679 — Disposable Cytology Brush (AF series) (March 4, 2025)
  • K231818 — METIC™- Airway Balloon Catheter (November 15, 2023)
  • K230778 — EndoCore (September 25, 2023)
  • K222187 — Multistage Balloon Dilatation Catheter (March 1, 2023)
  • K221206 — Compass Steerable Needle (August 25, 2022)