EMM Ultrasonic Transducer Cover
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211969 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)
The EMM Ultrasonic Transducer Cover is a protective barrier designed to shield ultrasound transducers during surgical procedures. It is classified as a sterile disposable device intended to maintain probe integrity while preventing contamination, ensuring optimal imaging performance and patient safety.
This cover is supplied in single-use, sterile packaging for direct clinical application or as bulk non-sterile items for repackaging and ethylene oxide sterilization. It is intended for intraoperative use with ultrasound systems and adheres to FDA 510(k) clearance (K211969) under the Radiology advisory committee. The product is tailored to fit specific transducer dimensions precisely, minimizing interference during use.
Frequently asked questions
What is the primary purpose of the EMM Ultrasonic Transducer Cover during surgery?
The EMM Ultrasonic Transducer Cover acts as a protective barrier to shield ultrasound transducers from contamination during surgical procedures. Its design ensures probe integrity is maintained, which helps preserve imaging performance and enhances patient safety by preventing cross-contamination.
Are the EMM Ultrasonic Transducer Covers single-use or reusable, and how are they sterilized?
The EMM Ultrasonic Transducer Covers are available in two forms: single-use, sterile packaging for direct clinical use, or bulk non-sterile items intended for repackaging and ethylene oxide sterilization. This flexibility allows facilities to choose based on their sterilization protocols and workflow needs.
How do I determine if the cover will fit my specific ultrasound transducer?
The EMM Ultrasonic Transducer Cover is designed to fit specific transducer dimensions precisely, so compatibility depends on matching the cover to your transducer’s size. Exact Medical Manufacturing tailors the fit to minimize interference during use, so verifying the transducer’s measurements against the available cover sizes is recommended.
What regulatory pathway does the EMM Ultrasonic Transducer Cover follow, and how was it cleared?
The EMM Ultrasonic Transducer Cover follows the FDA’s 510(k) clearance pathway under the Radiology advisory committee (RA). It was determined to be substantially equivalent to a predicate device and received clearance under the traditional review process with the clearance number K211969.
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: Home - Exact Medical, Exact Medical Manufacturing's Featured Product of the Month:, EMM Ultrasonic Transducer Cover (K211969) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211969 | Class II | Active |
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Manufacturer
- Manufacturer
- Exact Medical Manufacturing
Sources (1)
- FDA 510(k) K211969 24 fields · synced Oct 6, 2026