Cleared Traditional

Guided DAS Surgical Kit

K243425 · Talladium Espa?a, SL · General Hospital

Jul 2025

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K243425 is an FDA 510(k) clearance for the Guided DAS Surgical Kit, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Talladium Espa?a, SL (Lleida, ES). The FDA issued a Cleared decision on July 22, 2025, 260 days after receiving the submission on November 4, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K243425 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2024
Decision Date	July 22, 2025
Days to Decision	260 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