Cleared Traditional

Synthes Graphic Case & Tray System

K241927 · Synthes GmbH · General Hospital

Mar 2025

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K241927 is an FDA 510(k) clearance for the Synthes Graphic Case & Tray System, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on March 28, 2025, 270 days after receiving the submission on July 1, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K241927 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2024
Decision Date	March 28, 2025
Days to Decision	270 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850