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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K243407
Device Name Forcyte Autograft Harvest Kit
Applicant
Forcyte Medical, LLC
2275 Northwest Pkwy. SE, Suite 160
Marietta,  GA  30067
Applicant Contact Robert Assell
Correspondent
Wagoner Consulting, LLC
5215 Crosswinds Dr.
Wilmington,  NC  28409
Correspondent Contact Cheryl Wagoner
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/01/2024
Decision Date 07/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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