Cleared Traditional

Benesta Medical Sterilization Tray

K193603 · Caldera Medical, Inc. · General Hospital

Jul 2020

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K193603 is an FDA 510(k) clearance for the Benesta Medical Sterilization Tray, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on July 20, 2020, 210 days after receiving the submission on December 23, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K193603 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2019
Decision Date	July 20, 2020
Days to Decision	210 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

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