510(k) Report

Devices descending from K801760

5 later devices reach Field-Lee Brain Biopsy Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060808Brainpro, Brainpro AccessPAJUNK GmbH Medizintechnologie20063—
+1K974158Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided BiopsyOrtho Development Corp.19970—
+2K220897Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie20221—
+2K112094Brain Biopsy NeedleAd-Tech Medical Instrument Corp20120—
+3K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie20230—