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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 / August 2026 / K262571

510(k) cleared

EnCor EnCompass Breast Biopsy and Tissue Removal System

Bard Peripheral Vascular, Inc. · Aug 14, 2026 · K262571

FDA cleared the EnCor EnCompass Breast Biopsy and Tissue Removal System from Bard Peripheral Vascular, Inc. on Aug 14, 2026 under K262571, a special 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 Jul 24, 2026. The decision came 21 days later, inside the 90 FDA-day goal for a 510(k).

Bard Peripheral Vascular, Inc. has 2 other decisions in the tracker over the last 12 months: K260012 (UltraScore Focused Force PTA Balloon), K252681 (EnCor EnCompass Breast Biopsy and Tissue Removal System).

Questions & Answers

What did FDA clear under K262571?

K262571 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 Aug 14, 2026, 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 K262571.

How long did the K262571 review take?

FDA received the submission on Jul 24, 2026 and issued its decision on Aug 14, 2026, 21 days later.

← All decisions in August 2026

Sources