Class Class II
Intraoperative Ultrasound Probe Cover (K222460)
Description
Intraoperative Ultrasound Probe Cover by Exact Medical Manufacturing, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222460
Clearance Date2023-05-12
Clearance TypeTraditional
Product CodeITX
Regulation Number892.1570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222460
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Intraoperative Ultrasound Probe Cover (K222460) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | CIVCO Medical Instruments Co., Inc. | 2013 |
Trace the full predicate network for K222460
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.