Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Endotherapy and electrosurgical devices
/
Electrosurgery devices, single-use
/
Mono- and bipolar devices, single-use
/
Mono- and bipolar surgical instruments, single-use
/
Electrosurgery handpieces, single-use
Electrosurgery handpieces, single-use
K02010105
175 devices
Subcategories
2
K0201010501
Open electrosurgery handpieces, single-use
167
devices
K0201010502
Laparoscopic and thoracoscopic electrosurgery handpieces, single-use
8
devices
Devices
Huatong，fcare
Zhejiang Jinhua Huatong Medical Appliance Co., Ltd
·
,
China
Class IIb
CE/MDD
CE/MDR
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Electrosurgical pencils
Dongguan QueenMed Equipment Mfg Co Ltd
·
,
China
Class IIb
CE/MDD
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Disposable Bipolar Suction Coagulator 7 1/2 in. (19cm) 15 Fr
Kirwan Surgical Products LLC
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Disposable Electrosurgical Active Electrodes
Zhejiang Jinhua Huatong Medical Appliance Co., Ltd
·
,
China
Class IIb
CE/MDR
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Disposable Bipolar Suction Coagulator 5 1/2 in. (14cm) 13 Fr Curved
Kirwan Surgical Products LLC
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Disposable Bipolar Suction Coagulator 11 in. (28cm) 15 Fr
Kirwan Surgical Products LLC
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Aura
Kirwan Surgical Products LLC
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Electrosurgical Suction Irrigation System
Lagis Enterprise Co., Ltd.
·
,
Taiwan
Class IIb
FDA 510(k)
K243867
Active
Cleared 17 Mar 2025
CE/MDR
Endopath
Ethicon Endo-Surgery, LLC
·
,
United States
Class IIb
CE/MDR
GUDID
on market
Endopath
Ethicon Endo-Surgery, LLC
·
,
United States
Class IIb
CE/MDR
GUDID
on market
ENER REACH Enerseal
Reach Surgical, Inc.
·
,
China
Class IIb
CE/MDR
Previous
Next