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510(k) K152031

Device
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 W
Applicant
NEW DEANTRONICS TAIWAN, LTD.
510(k) number
K152031
Product code
GEI  
Decision
Substantially Equivalent (SESE)
Decision date
2015-09-17
Date received
2015-07-22
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JANE LIU
Address
12f, #51, Sec. 4, Chong Yang Rd. Tu Cheng City TW 23675 23675

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GEI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC2026-09-17
K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments2026-09-17
K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC2026-09-15
K254185Potenza PrimeJeisys Medical Incorporated2026-09-11
K262364Ellian Enigma RF DeviceEllian Corp2026-09-02
K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.2026-08-27
K252535Inno-Switch™ Laparoscopic InstrumentsTaiwan Surgical Corporation2026-08-25
K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH2026-07-22
K253504Volnewmer™Classys, Inc.2026-07-13
K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.2026-07-01
K251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.2026-06-29
K253484LUTRONIC GENIUSCynosure Lutronic Technology Corporation2026-06-29
K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions2026-06-18
K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc.2026-06-17
K261833NEUROMARK System (NMK00301)Neurent Medical , Ltd.2026-06-16

Legacy Summary#

summary

FDA Review#

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