FDA 510(k)

Pivot System Sterilization case

K-Number: K181845 · 2019-11-25

Decision Date2019-11-25

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Pivot System Sterilization case is a medical device manufactured by Rp Medical, Inc.. It received FDA 510(k) clearance on 2019-11-25 under approval number K181845. 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 Pivot System Sterilization case?

Pivot System Sterilization case is a medical device that received FDA 510(k) clearance on 2019-11-25. It is manufactured by Rp Medical, Inc.. The 510(k) number is K181845.

When was Pivot System Sterilization case approved by the FDA?

Pivot System Sterilization case received FDA 510(k) clearance on 2019-11-25, under approval number K181845.

What company makes Pivot System Sterilization case?

Pivot System Sterilization case is manufactured by Rp Medical, Inc..

What is the FDA product code for Pivot System Sterilization case?

The FDA product code for Pivot System Sterilization case is KCT.

Related Clinical Trials

NCT04610294 Operating Room Air Filtration/Sterilization ACTIVE_NOT_RECRUITING

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.