510(k) Report

Devices descending from K993801

6 later devices reach Gynecare Laparoscopic Morcellator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101458Lina Xcise Model Mor-1515Lina Medical Aps20111—
+1K091010Trokamed MorcellatorTrokamed GmbH201101
+1K080365Morce Power Plus and Variocarve MorcellatorNouvag AG20090—
+1K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+2K243821i-CutA.M.I. Agency For Medical Innovations GmbH20250—
+2K161038PK MorcellatorGyrus Acmi, Inc.20160—