Bard Peripheral Vascular, Inc. · Class II · Cleared Dec 12, 2025
| K-number | K252681 |
| Device name | EnCor EnCompass Breast Biopsy and Tissue Removal System |
| Applicant | Bard Peripheral Vascular, Inc. |
| Product code | KNW |
| Device class | Class II |
| Decision date | Dec 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1075 |
The EnCor EnCompass™ Breast Biopsy and Tissue Removal System is a console-based vacuum-assisted device designed to obtain breast tissue samples for diagnostic examination, with capability for partial or complete removal of the abnormality. It can be used under ultrasound, stereotactic, or MRI imaging guidance and consists of a console, handheld driver, foot switch, probes, and associated accessories.
The device shares the same intended use, indications, target population, principle of operation, and fundamental scientific technology as the predicate device (EnCor Enspire™ Breast Biopsy System). Key differences include an enhanced user interface, enhanced sampling options, reduced inventory requirements, addition of wireless technology, and changes to patient-contacting materials.
Testing was conducted per ISO 10993 Series, IEC 60601 Series, IEC 62366-1, IEC 62304, ASTM F2096, ASTM F2503, AAMI TIR12, ANSI AAMI ST98, plus FDA guidance documents on biocompatibility, human factors, MR safety, cybersecurity, and electromagnetic compatibility.
The EnCor EnCompass™ is substantially equivalent to the EnCor Enspire™ predicate device because they share identical intended use, indications, target population, principle of operation, imaging compatibility, sterility method, and packaging configuration. Comprehensive testing demonstrated that the device meets predetermined acceptance criteria and performs comparably to the predicate with no safety or effectiveness concerns related to the enumerated changes.
View the full FDA submission: accessdata.fda.gov