510(k) K243407

Forcyte Autograft Harvest Kit by Forcyte Medical, LLC — Product Code KNW

K243407 is an FDA 510(k) premarket notification submitted by Forcyte Medical, LLC for the device "Forcyte Autograft Harvest Kit". The FDA issued a decision of Substantially Equivalent on July 29, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2025
Date Received
November 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type