510(k) Report

Devices descending from K791137

10 later devices reach Single Use Monopolar Hand Control Pencil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143103PROPENCIL Smoke PencilBio Protech, Inc.20150—
+1K081634Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation20089—
+2K120454Safeair Smoke Pencil,Lna Medical Aps20128—
+3K143145SafeAir Smoke PencilLina Medical Aps201448
+3K142538LiNA SafeAir Smoke PencilLina Medical Aps20145—
+3K140384Fmwand Handpiece SEDomain Surgical, Inc.20140—
+4K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation20163—
+5K160693Neptune E-SEP Smoke Evacuation PencilStryker Corporation20162—
+6K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button…Stryker Instruments20260—
+6K182354SafeAir Telescopic Smoke PencilLina Medical Aps201804