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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 / K262792

510(k) cleared

Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)

Hologic, Inc. · Aug 12, 2026 · K262792

FDA cleared the Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) from Hologic, Inc. on Aug 12, 2026 under K262792, 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 Aug 6, 2026. The decision came 6 days later, inside the 90 FDA-day goal for a 510(k).

Hologic, Inc. has 3 other decisions in the tracker over the last 12 months: K253634 (CoolSeal Generator® (CSL-200-90)), K251868 (Panther Fusion GI Bacterial Assay), K251993 (Panther Fusion GI Expanded Bacterial Assay).

Questions & Answers

What did FDA clear under K262792?

K262792 is the FDA 510(k) for Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09), submitted by Hologic, Inc.. FDA's decision date was Aug 12, 2026, under product code KNW (Instrument, Biopsy).

Who makes the Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)?

Hologic, Inc., based in Malborough, MA, is the applicant of record for K262792.

How long did the K262792 review take?

FDA received the submission on Aug 6, 2026 and issued its decision on Aug 12, 2026, 6 days later.

← All decisions in August 2026

Sources