510(k) Report

Devices descending from K140495

6 later devices reach Leveen Standard Needle Electrode, Leveen Coaccess Needle Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150029Habib EUS RFAEmcision, Ltd.20155—
+2K181249EUSRA RF ElectrodeStarmed Co., Ltd.20182—
+2K170990Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorSpiration, Inc.20170—
+2K161305Habib EUS RFAEmcision, Ltd.201612
+3K240932HybridTherm SystemErbe Elektromedizin GmbH20241—
+4K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH20250—