510(k) Report

Devices descending from K010487

3 later devices reach Bipolar Pencil, Model 3901-002, 3900-002 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024304Microsurgical Bipolar HandpieceNeomedix Corp.20032—
+2K040584NMX-1000Neomedix Corp.20041—
+3K220891Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc.20240—