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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 the device name listed in this FDA 510(k) record. The listed applicant is Sheathing Technologies, Inc.. It received FDA 510(k) clearance on 2016-03-04 under 510(k) 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. The listed applicant is Sheathing Technologies, Inc.. The 510(k) number is K153212.

When did Sheathes Ultrasound Probe Covers receive FDA 510(k) clearance?

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

Who is the listed applicant for Sheathes Ultrasound Probe Covers?

The FDA 510(k) record lists Sheathing Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

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.

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