Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Jewel Precision Reusable Rigid Sterilization Container System

K-Number: K162600 · 2016-12-09

ApplicantJewel Precision Sheet Metal & Machine, Inc.
Decision Date2016-12-09
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Jewel Precision Reusable Rigid Sterilization Container System is a medical device manufactured by Jewel Precision Sheet Metal & Machine, Inc.. It received FDA 510(k) clearance on 2016-12-09 under approval number K162600. 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 Jewel Precision Reusable Rigid Sterilization Container System?

Jewel Precision Reusable Rigid Sterilization Container System is a medical device that received FDA 510(k) clearance on 2016-12-09. It is manufactured by Jewel Precision Sheet Metal & Machine, Inc.. The 510(k) number is K162600.

When was Jewel Precision Reusable Rigid Sterilization Container System approved by the FDA?

Jewel Precision Reusable Rigid Sterilization Container System received FDA 510(k) clearance on 2016-12-09, under approval number K162600.

What company makes Jewel Precision Reusable Rigid Sterilization Container System?

Jewel Precision Reusable Rigid Sterilization Container System is manufactured by Jewel Precision Sheet Metal & Machine, Inc..

What is the FDA product code for Jewel Precision Reusable Rigid Sterilization Container System?

The FDA product code for Jewel Precision Reusable Rigid Sterilization Container System is KCT.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07574632 A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis. NOT_YET_RECRUITING NCT04610294 Operating Room Air Filtration/Sterilization ACTIVE_NOT_RECRUITING

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. K152969ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAYConmed Corporation

Official Source

View on FDA Database →

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

↑