InstruSafe By Summit Medical, an Innovia Medical Company


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.

InstruSafe Trays are cleared for:

 *For compatible rigid container size information, see Appendix A in the InstruSafe IFU.

*Click on the sterilization cycle name for a link to the FDA 510(k) premarket notification.

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 understand that with each additional FDA clearance comes increased flexibility for our customers, which is why we’re committed to providing as many sterilization cycle options as possible. We follow through on this commitment with continuous product development and validation testing.

As low temperature sterilization has become more popular for delicate medical devices the need for manufacturers to support these cycles has increased. We are constantly working to validate our InstruSafe products for a variety of available STERRAD and STERIS V-Pro cycles. We also recognize that low-temperature sterilization technology continues to improve, so our efforts to obtain clearances for new cycles are ongoing.

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