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)

Clear Guide SCENERGY

K-Number: K171677 · 2017-12-08

ApplicantClear Guide Medical
Decision Date2017-12-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Clear Guide SCENERGY is a medical device manufactured by Clear Guide Medical. It received FDA 510(k) clearance on 2017-12-08 under approval number K171677. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clear Guide SCENERGY?

Clear Guide SCENERGY is a medical device that received FDA 510(k) clearance on 2017-12-08. It is manufactured by Clear Guide Medical. The 510(k) number is K171677.

When was Clear Guide SCENERGY approved by the FDA?

Clear Guide SCENERGY received FDA 510(k) clearance on 2017-12-08, under approval number K171677.

What company makes Clear Guide SCENERGY?

Clear Guide SCENERGY is manufactured by Clear Guide Medical.

What is the FDA product code for Clear Guide SCENERGY?

The FDA product code for Clear Guide SCENERGY is JAK.

Related Clinical Trials

NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT05643144 Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes RECRUITING NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07562269 Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds NOT_YET_RECRUITING NCT07079111 3D Printed Occlusal Splints for Intraoperative Use NOT_YET_RECRUITING

Other Devices by Clear Guide Medical

K153004Clear Guide SCENERGY K201188Clear Guide SCENERGY K201898Clear Guide SCENERGY K234030Clear Guide SCENERGY

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

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.

↑