FDA Clears BD's EnCor EnCompass Multi-Modality Breast Biopsy System
The vacuum-assisted system, which succeeds BD's EnCor Enspire, adds wireless foot-switch connectivity and new sampling options, and BD expects it on the market in early 2026.
The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- The FDA cleared the EnCor EnCompass Breast Biopsy and Tissue Removal System under 510(k) K252681 on December 12, 2025; BD announced it on January 15, 2026.
- The predicate is BD's own EnCor Enspire system, cleared in 2023; the 510(k) summary lists the same intended use and indications.
- The system can be used under ultrasound, stereotactic or MRI guidance and offers 12G, 10G and 7G probes.
The US Food and Drug Administration has cleared BD's EnCor EnCompass Breast Biopsy and Tissue Removal System, a vacuum-assisted device for taking breast tissue samples that can be used with several types of breast imaging, the company announced on January 15.
The FDA's 510(k) database lists the clearance as K252681, submitted by BD subsidiary Bard Peripheral Vascular. The agency received the submission on August 25, 2025, and found the device substantially equivalent on December 12, 2025. It is classed as a biopsy instrument and was reviewed by the general and plastic surgery panel.
What the system includes
According to the clearance letter and 510(k) summary, the device is a console-based system with a handheld driver, foot switch and disposable biopsy probes, and may be used under ultrasound, stereotactic or MR imaging guidance. The console holds the vacuum system and a touchscreen, and the foot switch has wired and wireless connection options. Each probe has a tubular cutter, a chamber that collects samples as they are taken and a line for optional saline lavage.
The cleared indication is to "acquire breast tissue for histologic examination with partial or complete removal of the abnormality."
The predicate is BD's own EnCor Enspire Breast Biopsy System, cleared in October 2023 as K233220. The summary says the new system has the same intended use, indications, patient population, principle of operation and imaging compatibilities. It lists the changes as an enhanced user interface, enhanced sampling options, reduced inventory requirements, wireless technology and patient-contacting materials. Testing cited includes performance, biocompatibility, human factors, software, cybersecurity, wireless and MR safety work; no clinical study is listed.
What BD says
BD said the system is expected to enter the market in early 2026. Features it highlighted include high and low vacuum strengths, a sample notch that can be adjusted during the procedure, 360-degree sampling, an echogenic cutting cannula and an illuminated sample container, with a choice of 12G, 10G and 7G probes.
"This milestone for our new breast biopsy system marks a meaningful advancement in breast health, playing a critical role in aiding the early detection and diagnosis of breast disease," said Rima Alameddine, worldwide president of Peripheral Intervention at BD, in the release.
Shadi Aminololama-Shakeri, chief of breast radiology at UC Davis, said in the release that the system "combines multi-modality capability and enhanced control into one platform." BD did not disclose pricing.
Sources
- BD Receives FDA 510(k) Clearance for EnCor EnCompass Breast Biopsy and Tissue Removal System, BD, January 15, 2026
- 510(k) K252681: EnCor EnCompass Breast Biopsy and Tissue Removal System (database record), US Food and Drug Administration, December 12, 2025
- K252681 clearance letter and 510(k) summary, US Food and Drug Administration, December 12, 2025