Cleared Traditional

Forcyte Autograft Harvest Kit

K243407 · Forcyte Medical, LLC · Orthopedic
Jul 2025
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K243407 is an FDA 510(k) clearance for the Forcyte Autograft Harvest Kit, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Forcyte Medical, LLC (Marietta, US). The FDA issued a Cleared decision on July 29, 2025, 270 days after receiving the submission on November 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K243407 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2024
Decision Date July 29, 2025
Days to Decision 270 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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