SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)— 510(k) K262720
Substantially EquivalentSingle Pass, Inc.
FDA 510(k) clearance K262720 for SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max), Substantially Equivalent on 2026-10-26. Applicant: Single Pass, Inc.. Device class: 2.
Clearance details
- Device name as filed
- SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max)
- 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
- Traditional
- Location
- Lake Forest, CA, US
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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.