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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K260287
Device Name SP Electrocautery Device (SP20)
Applicant
Single Pass, Inc.
105 N. Pt.e Dr.
Lake Forest,  CA  92630
Applicant Contact Greg Geissinger
Correspondent
Geissinger Regulatory Consulting, Inc.
6 Basilica Pl.
Ladera Ranch,  CA  92694
Correspondent Contact Greg Geissinger
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/29/2026
Decision Date 02/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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