Single Pass, Inc. · Class II · Cleared Feb 24, 2026
| K-number | K260287 |
| Device name | SP Electrocautery Device (SP20) |
| Applicant | Single Pass, Inc. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Feb 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
The SP Electrocautery Device (SP20) is a single-use, battery-powered electrocautery instrument designed to achieve hemostasis through coagulation of soft tissue in the liver, kidney, and lung following percutaneous biopsy. It consists of an ergonomic handpiece with two AA alkaline batteries and control electronics connected to a stainless-steel probe shaft with a heated distal segment that maintains a target temperature of 75-100°C.
The SP20 uses the same fundamental battery-powered thermally heated stainless-steel probe with thermistor-based temperature control as the predicate device, operating at 75-100°C. The key differences are a reduction in shaft diameter from 18 gauge to 20 gauge and a minor distal tip redesign where the shaft is sealed at the distal end without a separate end cap.
Not stated in this summary. The document references internal protocols and established methods but does not cite specific ISO, IEC, or ASTM standards.
The SP20 is substantially equivalent because it shares the same intended use, identical fundamental scientific technology, and same temperature control operating range as the predicate device. Non-clinical testing including simulated-use usability and thermal characterization demonstrated that the SP20 meets predetermined acceptance criteria and introduces no new questions of safety or effectiveness despite the minor shaft diameter and tip design modifications.
View the full FDA submission: accessdata.fda.gov