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Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

Page Type
Product Code
Definition
Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.
Physical State
Applicator/Dissector, RF Generator and Battery are integrated in a single handpiece.
Technical Method
Application of RF energy to heat and seal vessel/tissue followed by dissection of target vessel/tissue.
Target Area
Has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4400 Electrosurgical cutting and coagulation device and accessories

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.

Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

Page Type
Product Code
Definition
Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.
Physical State
Applicator/Dissector, RF Generator and Battery are integrated in a single handpiece.
Technical Method
Application of RF energy to heat and seal vessel/tissue followed by dissection of target vessel/tissue.
Target Area
Has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4400 Electrosurgical cutting and coagulation device and accessories

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.