DeviceClearance

Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)— 510(k) K262792

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K262792 for Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09), Substantially Equivalent on 2026-08-12. Applicant: Hologic, Inc.. Device class: 2.

Summary

Hologic filed the Brevera Biopsy System with CorLumina Imaging Technology, listed as BREVDISP09, under product code KNW, biopsy instruments.

Class II, 21 CFR 876.1075. The General and Plastic Surgery review panel handled it as a Special 510(k), though the record lists Gastroenterology and Urology as the classification panel.

The record lists the applicant location as Malborough, Massachusetts. FDA found it substantially equivalent 6 calendar days after receipt (August 6 to August 12, 2026).

Clearance details

Applicant
Hologic, Inc.
Product code
Product code KNW
Device class
Class 2
Regulation
21 CFR 876.1075
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Malborough, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KNW

product code KNW
Death
9
Injury
965
Malfunction
10,444
Other
3
Total
11,421

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.