Cleared Traditional

Standard Sterilizable Tray

K202524 · Implant Direct Sybron Manufacturing, LLC · General Hospital

Jan 2021

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K202524 is an FDA 510(k) clearance for the Standard Sterilizable Tray, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on January 28, 2021, 149 days after receiving the submission on September 1, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K202524 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2020
Decision Date	January 28, 2021
Days to Decision	149 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