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FDA 510(k)

Sheathes Ultrasound Probe Covers

K-Number: K153212 · 2016-03-04

ApplicantSheathing Technologies, Inc.
Decision Date2016-03-04
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sheathes Ultrasound Probe Covers is a medical device manufactured by Sheathing Technologies, Inc.. It received FDA 510(k) clearance on 2016-03-04 under approval number K153212. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sheathes Ultrasound Probe Covers?

Sheathes Ultrasound Probe Covers is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Sheathing Technologies, Inc.. The 510(k) number is K153212.

When was Sheathes Ultrasound Probe Covers approved by the FDA?

Sheathes Ultrasound Probe Covers received FDA 510(k) clearance on 2016-03-04, under approval number K153212.

What company makes Sheathes Ultrasound Probe Covers?

Sheathes Ultrasound Probe Covers is manufactured by Sheathing Technologies, Inc..

What is the FDA product code for Sheathes Ultrasound Probe Covers?

The FDA product code for Sheathes Ultrasound Probe Covers is ITX.

Related Clinical Trials

NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07602933 Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES NOT_YET_RECRUITING NCT05809427 High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases COMPLETED NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT07550361 Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients WITHDRAWN NCT07548086 Light-Based Monitoring (SR-NIRS) for Suspected Testicular Torsion in Children NOT_YET_RECRUITING

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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.

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