FDA 510(k)

InstruSafe(R) Sterilization Container

K-Number: K180528 · 2018-11-16

Decision Date2018-11-16

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

InstruSafe(R) Sterilization Container is a medical device manufactured by Summit Medical, Inc.. It received FDA 510(k) clearance on 2018-11-16 under approval number K180528. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InstruSafe(R) Sterilization Container?

InstruSafe(R) Sterilization Container is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Summit Medical, Inc.. The 510(k) number is K180528.

When was InstruSafe(R) Sterilization Container approved by the FDA?

InstruSafe(R) Sterilization Container received FDA 510(k) clearance on 2018-11-16, under approval number K180528.

What company makes InstruSafe(R) Sterilization Container?

InstruSafe(R) Sterilization Container is manufactured by Summit Medical, Inc..

What is the FDA product code for InstruSafe(R) Sterilization Container?

The FDA product code for InstruSafe(R) Sterilization Container is KCT.

Other Devices by Summit Medical, Inc.

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Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.