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510(k) K974793

Device
ELMED ESU 120 M/M DIGITAL
Applicant
ELMED, INC.
510(k) number
K974793
Product code
GEI  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-19
Date received
1997-12-22
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
WERNER HAUSNER
Address
60 W. Fay Ave. Addison IL US 60101 60101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

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FDA Review#

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