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HTx Procedure Pack

Suzhou AcuVu medical technology Co., Ltd. · Model inflow tubing+ drainage fluid tube + under buttocks drape · UDI-DI 06974880991427

NWW

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The procedure pack is an accessory kit of the HTx disposable hysteroscope system, which contains an inflow tubing, a drainage fluid tube and an under buttocks drape. The inflow tubing contains a luer connector and a non-vented spile, and is used to connect the inflow port of the HTx hysteroscope and the saline bag to provide the distension fluid inflow. The drainage fluid tube contains a luer connector, and is used to be connected to the outflow port of the hysteroscope for the discharge of fluid. The under buttocks drape is used to be placed under the patients’ buttocks and contains a fluid collection pouch to collect the discharged fluid.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.