FDA.reportPublic FDA data

510(k) K222460

Device
Intraoperative Ultrasound Probe Cover
Applicant
Exact Medical Manufacturing
510(k) number
K222460
Product code
ITX
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-12
Date received
2022-08-15
Regulation
892.1570
Classification name
Transducer, Ultrasonic, Diagnostic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ryan Power
Address
21# Qingjjiang Rd. Xinbei District Changzhou Jiangsu CN 213022 213022

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ITX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation2025-09-18
K250762ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)Olympus Medical Systems Corporation2025-07-11
K250524Mendaera Guidance SystemMendaera, Inc.2025-07-02
K250469Accuro® 3S Needle Guide KitRivanna Medical, Inc.2025-06-13
K241662Ultrasound Transducer CoverVitrolife Sweden AB2024-08-30
K233965UltraDrape UGPIV Barrier and Securement (34-15)Parker Laboratories, Inc.2024-08-15
K241615Transducer Probe CoverHony Medical Co., Ltd.2024-07-03
K233109TP Pivot Pro™ Needle GuideCivco Medical Solutions2023-12-22
K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)FUJIFILM Healthcare Americas Corporation2023-12-13
K231783VitroPROCIVCO Medical Instruments Co., Inc.2023-11-14
K223689Disposable Needle Guides and GridsAdvance Medical Designs, Inc.2023-08-02
K221278Transducer Probe CoverHony Medical Co., Ltd.2023-01-11
K222052VitroPROCIVCO Medical Instruments Co., Inc.2022-11-22
K213087Natural Rubber Latex Ultrasound Transducer Probe CoversGlobal Protection Corp.2022-06-07
K211270CIV-Clear coverCIVCO Medical Instruments Co., Inc.2021-09-13