510(k) clearance
SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max)
- 510(k) number
- K262720
- Applicant
- Single Pass, Inc.
- Decision date
- Oct 26, 2026
- Date received
- Jul 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GEI
- Device type
- Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II
- Regulation
- 21 CFR 878.4400
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Lake Forest, CA, US