SCHILLER PARK, Ill. — Mastel Surgical has received U.S. Food and Drug Administration 510(k) clearance for its SteriBest Sterilization Tray System for use with a four-minute, 270-degree Fahrenheit pre-vacuum steam sterilization cycle.
The system is designed to organize, protect, store and transport delicate surgical instruments during reprocessing. It is intended for use in operating rooms and sterile processing departments handling microsurgical, ophthalmic and other high-value medical instruments.
SteriBest is available in multiple sizes and configurations, including versions equipped with pin mats, silicone bars and specialty holders. Mastel Surgical also offers private-label configurations for original equipment manufacturers.
The trays are made in the United States using durable Ultem polymer and feature transparent lids to make instrument identification easier. Their stackable design is intended to improve storage efficiency, while slotted lids and bases support steam circulation and rapid drying.
“This FDA 510(k) clearance marks an important milestone for SteriBest® and for healthcare professionals who rely on efficient, validated reprocessing workflows,” said Steve Sharpless, President of Mastel Surgical. “SteriBest® was developed to help protect and organize delicate instruments while supporting facilities in standardizing their sterilization processes with added confidence.”
Mastel Surgical said the clearance allows healthcare facilities to use the tray system as part of a validated steam sterilization workflow. The company is also marketing SteriBest to manufacturers seeking customizable, FDA-cleared sterilization tray products for their own medical device portfolios.
Mastel Surgical is a Pacific Surgical company.
