510(k) Report

Devices descending from K092309

15 later devices reach Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…Olympus Medical Systems Corporation20250—
+1K212999Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd.20220—
+1K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare…Hangzhou AGS MedTech Co., Ltd.20200—
+1K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.201772
+1K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.20171—
+1K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd.201602
+1K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc.20163—
+2K200404ORISE ProKnifeBoston Scientific Corporation20200—
+2K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd.20201—
+2K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd.20200—
+2K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp.201913
+2K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc.20162—
+3K211172Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd.20210—
+3K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc.20171—
+4K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm Corporation20220—