SP Electrocautery Device (SP20)— 510(k) K260287
Substantially EquivalentSingle Pass, Inc.
FDA 510(k) clearance K260287 for SP Electrocautery Device (SP20), Substantially Equivalent on 2026-02-24. Applicant: Single Pass, Inc.. Device class: 2.
Summary
Single Pass filed the SP Electrocautery Device (SP20) under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). The record gives no description beyond the name and that code name.
Class II, 21 CFR 878.4400. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Special 510(k).
Single Pass filed from Lake Forest, California. Review took 26 calendar days (January 29 to February 24, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Single Pass, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lake Forest, CA, US
Recent devices under product code GEI
view all- K262720 — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)
- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
More clearances from Single Pass, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.