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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K252681

510(k) cleared

EnCor EnCompass Breast Biopsy and Tissue Removal System

Bard Peripheral Vascular, Inc. · Dec 12, 2025 · K252681

FDA cleared the EnCor EnCompass Breast Biopsy and Tissue Removal System from Bard Peripheral Vascular, Inc. on Dec 12, 2025 under K252681, a traditional 510(k). The device falls under product code KNW, Instrument, Biopsy, regulated at 21 CFR 876.1075 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 25, 2025. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bard Peripheral Vascular, Inc. has 2 other decisions in the tracker over the last 12 months: K262571 (EnCor EnCompass Breast Biopsy and Tissue Removal System), K260012 (UltraScore Focused Force PTA Balloon).

Questions & Answers

What did FDA clear under K252681?

K252681 is the FDA 510(k) for EnCor EnCompass Breast Biopsy and Tissue Removal System, submitted by Bard Peripheral Vascular, Inc.. FDA's decision date was Dec 12, 2025, under product code KNW (Instrument, Biopsy).

Who makes the EnCor EnCompass Breast Biopsy and Tissue Removal System?

Bard Peripheral Vascular, Inc., based in Tempe, AZ, is the applicant of record for K252681.

How long did the K252681 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Dec 12, 2025, 109 days later.

← All decisions in December 2025

Sources