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The SP Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.

The SP Electrocautery Device is a single-use, disposable, battery-powered electrocautery instrument used to achieve hemostasis through coagulation of soft tissue in liver, kidney, and lung following percutaneous biopsy. The device consists of an ergonomic handpiece containing two AA alkaline batteries and control electronics connected to a stainless-steel probe shaft with a heated distal segment. When activated, electrical current heats a resistive element near the distal tip, and a thermistor provides feedback to a closed-loop controller to maintain a target operating temperature range of approximately 75-100 °C while the clinician advances or withdraws the probe within the biopsy tract.

The Single Pass device family includes multiple probe configurations that share the same handle, electronics, power source, temperature control algorithm, and patient-contact materials. This Special 510(k) introduces a new 20-gauge (GA) shaft configuration (SP20) designed for use through smaller-diameter biopsy tracts. SP20 uses the same internal heater and thermistor design and operates over the same controlled temperature range as the existing configurations. The only physical differences are a reduced shaft outer diameter (20 GA) and a minor distal tip redesign in which the shaft is sealed at the distal end without a separate end cap. Sterilization method (EtO), packaging configuration, labeled shelf life, indications for use, and intended users remain unchanged.

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