FDA 510(k)

Transducer Probe Cover

K-Number: K221278 · 2023-01-11

Decision Date2023-01-11

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Transducer Probe Cover is a medical device manufactured by Hony Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-01-11 under approval number K221278. 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 Transducer Probe Cover?

Transducer Probe Cover is a medical device that received FDA 510(k) clearance on 2023-01-11. It is manufactured by Hony Medical Co., Ltd.. The 510(k) number is K221278.

When was Transducer Probe Cover approved by the FDA?

Transducer Probe Cover received FDA 510(k) clearance on 2023-01-11, under approval number K221278.

What company makes Transducer Probe Cover?

Transducer Probe Cover is manufactured by Hony Medical Co., Ltd..

What is the FDA product code for Transducer Probe Cover?

The FDA product code for Transducer Probe Cover is ITX.

Other Devices by Hony Medical Co., Ltd.

K221999Ultrasound Transmission Gels K241789Non-Sterile Ultrasound Transmission Gels K241615Transducer Probe Cover

Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc.

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.