510(k) Report

Devices descending from K031082

15 later devices reach Everest Bipolar L Hook & PK Bipolar L Hook through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+1K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+2K142350PK J-HookGyrus Acmi, Inc.201511
+2K142289PK SpatulaGyrus Acmi, Inc.20141—
+2K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+2K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+2K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+3K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+3K161038PK MorcellatorGyrus Acmi, Inc.20160—
+3K161825PK AIMGyrus Acmi, Inc.20162—
+3K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+3K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+3K122605PKS BillGyrus Acmi, Inc.20121—
+4K163373PK AIMGyrus Acmi, Inc.20161—
+5K170908PK AIMGyrus Acmi, Inc.20170—