Cleared Traditional

PRO-LITE Sterilization Tray

K231501 · STERIS Corporation · General Hospital

Aug 2023

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K231501 is an FDA 510(k) clearance for the PRO-LITE Sterilization Tray, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 7, 2023, 75 days after receiving the submission on May 24, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K231501 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2023
Decision Date	August 07, 2023
Days to Decision	75 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