ANDORATE® Valve Kit— 510(k) K232118

Substantially Equivalent

Ga Health Company Limited

FDA 510(k) clearance K232118 for ANDORATE® Valve Kit, Substantially Equivalent on 2023-10-16. Applicant: Ga Health Company Limited. Device class: 2.

Clearance details

Applicant: Ga Health Company Limited
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-07-17
Decision date: 2023-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Ga Health Company Limited

K231602 — Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing2023-08-01
K230932 — ANDORATE® Valve Kit2023-07-07
K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve2023-05-11
K223171 — AquaPulse® Irrigation Tubing2022-11-10
K213095 — andorate Suction Valve, andorate Air/Water Valve2022-01-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.