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FDA 510(k)

Intraoperative Ultrasound Probe Cover

K-Number: K222460 · 2023-05-12

ApplicantExact Medical Manufacturing
Decision Date2023-05-12
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Intraoperative Ultrasound Probe Cover is the device name listed in this FDA 510(k) record. The listed applicant is Exact Medical Manufacturing. It received FDA 510(k) clearance on 2023-05-12 under 510(k) number K222460. 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 Intraoperative Ultrasound Probe Cover?

Intraoperative Ultrasound Probe Cover is a medical device that received FDA 510(k) clearance on 2023-05-12. The listed applicant is Exact Medical Manufacturing. The 510(k) number is K222460.

When did Intraoperative Ultrasound Probe Cover receive FDA 510(k) clearance?

Intraoperative Ultrasound Probe Cover received FDA 510(k) clearance on 2023-05-12, under 510(k) number K222460.

Who is the listed applicant for Intraoperative Ultrasound Probe Cover?

The FDA 510(k) record lists Exact Medical Manufacturing as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intraoperative Ultrasound Probe Cover?

The FDA product code for Intraoperative Ultrasound Probe Cover is ITX.

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Other records listing Exact Medical Manufacturing as applicant

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K211969EMM Ultrasonic Transducer Cover

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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