Cleared Traditional

Guided Surgery Kit Cases

K241492 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · General Hospital

Aug 2024

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K241492 is an FDA 510(k) clearance for the Guided Surgery Kit Cases, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. (Curitiba, BR). The FDA issued a Cleared decision on August 23, 2024, 87 days after receiving the submission on May 28, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K241492 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2024
Decision Date	August 23, 2024
Days to Decision	87 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