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Sheathes Ultrasound Probe Covers

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K153212

by Sheathing Technologies, Inc.

Identifiers

510(k) Number
K153212 FDA 510(k)
FDA Product Code
ITX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1570 FDA 510(k)
Regulation Number
892.1570 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Sheathes Ultrasound Probe Covers are sterile or non-sterile protective barriers designed to encase ultrasound probes. These covers shield probes from contamination, ensuring hygiene and preventing cross-infection during diagnostic imaging procedures.

These covers are supplied in single-use or reusable configurations, depending on the model, and are intended for use in clinical settings such as radiology departments. They are available in various sizes, including 1-1/4" x 8", and comply with FDA 510K and MDR regulatory standards. Storage requirements vary by sterility classification, and compatibility with MRI environments must be verified per manufacturer guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ultrasound Probe Covers | Sheathes, Sheathes Ultrasound Probe Covers - Medline, 20001 Endocavity | Sheathes, PT# 10001 Ultrasound Probe Cover Sheath 10001 Box/100 by Sheathing ..., Sheathing Technologies, Inc. Ə Ms. Jennifer Downing SR MGR of ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sheathing Technologies, Inc.

Sources (2)

  • FDA 510(k) K153212 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026