FDA 510(k) Clearance Quick Reference Chart

InstruSafe Trays have a 510(k) clearance for each sterilization cycle listed when using wrap as a sterile barrier and as indicated when using with rigid containers.
*Click on the sterilization cycle name for a link to the FDA 510(k) premarket notification.

InstruSafe Trays are cleared for:

 *For compatible rigid container size information, see Appendix A in the back of the InstruSafe IFU.
Sterilization Cycle Wrap Aesculap Rigid Container Genesis Rigid Container
Steam 4 minute x x x
Ethylene Oxide x x
STERRAD® 100S Standard x x
STERRAD® 100NX Standard x x
STERRAD® 100NX Express x
STERRAD® 100NX Flex x x
STERRAD® NX Standard x x
Steris® V-PRO® 1, V-PRO 1 Plus and V-PRO maX x x


At Summit Medical, we are committed to providing as many sterilization cycle options as possible providing you the flexibility your facility needs.

We are constantly working to validate our InstruSafe products for variety of available sterilization cycles like STERRAD, STERIS V-Pro, and low- temperature cycles as well as obtain clearances for new cycles.

Get Exactly What You Need. Customizable Trays for Every Instrument.

Summit Medical, an Innovia Medical Company, is a medical device manufacturer located in St. Paul, Minn. The company was founded in 1982 with the mission of developing, manufacturing and marketing products for microsurgery. Learn More

Secured By miniOrange