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HOLOGIC INC

BREVERA · Gastroenterology and Urology

510(k): 2 Recall: 1 UDI: 15 MAUDE: 10 Class.: 0

510(k) Clearances (2)

2017-03-29

Substantially Equivalent

Recalls (1)

2025-12-15

Presence of particulates in affected devices that can be deposited into breast tissue during use.

UDI Registrations (15)

Brevera Breast Biopsy System

A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system.

Brevera Breast Biopsy System

Reusable Driver

Brevera Breast Biopsy System

Kit used with a stereotactic guidance system compatible with Brevera(R) .

Brevera Breast Biopsy System

Kit used with a stereotactic guidance system compatible with Brevera(R) .

Brevera Breast Biopsy System

Stylet Bracket

Brevera Breast Biopsy System

Single chamber tissue filter assesmbly to collect biopsy core for imaging.

Brevera Breast Biopsy System

A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system.

Brevera Breast Biopsy System

Kit used with a stereotactic guidance system compatible with Brevera(R).

Brevera Breast Biopsy System

Single-use, disposable needle for acquiring biopsy specimens.

Brevera Breast Biopsy System

The reusable device driver is the electromechanical component of the Brevera(R) (R) Breast Biopsy system.

Brevera Breast Biopsy System

A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system.

Brevera Breast Biopsy System

Vacuum-assisted biopsy device used to remove breast tissue in a minimally invasive manner using stereotactic or tomosyntheses imaging.

Brevera Breast Biopsy System

Single chamber tissue filter assesmbly to collect biopsy core for imaging.

Brevera Breast Biopsy System

Single-use, disposable needle for acquiring biopsy specimens.

Brevera Breast Biopsy System

Vacuum-assisted biopsy device used to remove breast tissue in a minimally invasive manner using stereotactic or tomosyntheses imaging.

MAUDE Adverse Events (10)

Injury
20211112
Malfunction
20211112
Injury
20211008
Injury
20210826
Injury
20210806
Malfunction
20210517
Malfunction
20210424
Injury
20210303
Malfunction
20200921
Malfunction
20200306