Cleared Traditional

PAL Sterilization Case

K243589 · Microaire Surgical Instruments, LLC · General Hospital

Jun 2025

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K243589 is an FDA 510(k) clearance for the PAL Sterilization Case, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on June 20, 2025, 212 days after receiving the submission on November 20, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K243589 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2024
Decision Date	June 20, 2025
Days to Decision	212 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