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Found 9 results
510(k) Data Aggregation
K Number
K200455Device Name
Trigger Switch and Cord
Manufacturer
New Deantronics Taiwan, Ltd.
Date Cleared
2020-03-31
(35 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
New Deantronics Taiwan, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic instruments is desired.
Device Description
The Trigger Switch and Cord are an electrical connecting cord assembly, intended to provide an electrical path between an RF electrosurgery generator and an RF surgical electrode. The insulated wire of the Cord is 10ft long. The Cord is intended to be plugged into an in-line Trigger Switch which is attached to the RF electrode handle with an adhesive backing. The Trigger Switch allows hand switching of the electrical current through the Cord during surgery. These devices can be used in hospitals and are used by trained professionals only.
The Trigger Switch and Cord are compatible with the monopolar instruments with a shrouded 4mm male electrical connector and with an electrosurgical generator.
Typically, these application devices are used in place of foot switches in the flow of electrosurgical current to the target site.
These devices are sold as sterile, single-use devices.
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K Number
K153265Device Name
New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
Manufacturer
New Deantronics Taiwan, Ltd.
Date Cleared
2016-01-05
(54 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
New Deantronics Taiwan, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
Device Description
The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only.
The New Deantronics disposable laparoscopic electrodes are used in conjunction with monopolar electrosurgical pencils that accept 2.36 mm connectors, trocars or cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During the operation, the electrode and the insulated shaft are to be inserted through a trocar and the conductive shaft end is inserted into the nose of the electrosurgical pencil from which it receives the high frequency current while contacting target tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use.
The New Deantronics laparoscopic electrodes consists of four distinct sections, including a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector.
There are two groups of laparoscopic electrodes, including non-coated and coated laparoscopic electrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with non-sticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths.
There are sixteen models of New Deantronics laparoscopic electrodes available.
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K Number
K152031Device Name
New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
2015-09-17
(57 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS TAIWAN, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The New Deantronics Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil, improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator.
Device Description
The Smoke Evacuation Adapter is a single-use device provided to healthcare professionals. This device is an accessory to an electrosurgical pencil. The Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator. The device components include a pencil holding clamp, an electrosurgical pencil wire holder, smoke evacuator tubing pathway to the smoke evacuator, and a connector to the smoke evacuator. The clamp secures the smoke evacuation pencil adapter to the bottom of the pencil handle. Suction to remove smoke and odors is created by a smoke evacuator device furnished by the user organization. The smoke evacuator maintains a low pressure condition by a suction pump.
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K Number
K982748Device Name
BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
1998-11-03
(89 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS TAIWAN, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical accessory. BiPolar Cord Set for use with foot switching electrosurgical accessories to conduct high-frequency electrical current intended to remove tissue and control bleeding.
Device Description
New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets.
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K Number
K982742Device Name
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
1998-09-14
(39 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS TAIWAN, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
Device Description
Disposable Hand Switching Pencil, Rocker Switch, One Piece
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K Number
K982743Device Name
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
1998-09-14
(39 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS TAIWAN, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
Device Description
Model SB 313 PB and SB 313 PBH Disposable Hand Switching Pencil, Push Button, One Piece Body. With and Without Holster
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K Number
K982746Device Name
MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
1998-09-14
(39 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS TAIWAN, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical accessory. Monopolar electrosurgical coagulator for controlling bleeding by use of high-frequency electrical current and a suction tube for removal of fluids and debris from the surgical site.
Device Description
Monopolar Suction Coagulator
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K Number
K982749Device Name
MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
1998-09-14
(39 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS TAIWAN, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical accessory. A foot activated electrosurgical pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
Device Description
Monopolar Foot Control Pencil, Model # SB 112-2
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K Number
K982744Device Name
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
1998-09-11
(36 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEW DEANTRONICS TAIWAN, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical accessory. Hand switching, disposable pencil intended to remove the survey of the comments of and stricel overant Electrosurgicul accousery. Thanks of high-frequency electrical current.
Device Description
Model SB 312 PB and SB 32 PBH Disposable Hand Switching Pencil, Push Button, Two Piece Body, With and Without Holster
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