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510(k) K153499

Device
EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension
Applicant
ConMed Corporation
510(k) number
K153499
Product code
GEI  
Decision
Substantially Equivalent (SESE)
Decision date
2015-12-18
Date received
2015-12-07
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dionne Sanders
Address
525 French Rd. Utica NY US 13502 13502

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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