510(k) K153212 ยท ITX Transducer, Ultrasonic, Diagnostic
Sheathes Ultrasound Probe Covers
| Applicant | Sheathing Technologies, Inc., Morgan Hill CA, US |
| Decision | Substantially Equivalent, Mar 4, 2016 |
| Received | Nov 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2025 | Sheathing Technologies Inc Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Indivi Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.