ClearanceBrief
Panels › General, Plastic Surgery › Product code GEI · Class 2

Electrosurgical, Cutting & Coagulation & Accessories

Regulation 878.4400

48510(k)s in 12 months (2,320 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
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Top companies in GEI

Company510(k)sRecalls
ArthroCare Corporation865
Conmed Corporation2553
Valleylab690
Megadyne Medical Products, Inc.3231
Covidien4114
Carefusion 2200, Inc.245
Stryker935
Conmedcorp430
Gyrus Acmi, Inc.2120
Bovie Medical2115
Decided510(k)Device and applicantCode
Oct 20, 2026K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-00
Stryker Instruments
GEI
Sep 17, 2026K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® Sa
Stryker Instruments
GEI
Sep 17, 2026K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
Ethicon Endo-Surgery, LLC
GEI
Sep 15, 2026K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
Covidien, LLC
GEI
Sep 11, 2026K254185Potenza Prime
Jeisys Medical Incorporated, KR
GEI
Sep 2, 2026K262364Ellian Enigma RF Device
Ellian Corp
GEI
Aug 27, 2026K253859Scarlet Pro (Scarlet Pro)
VIOL Co., Ltd., KR
GEI
Aug 25, 2026K252535Inno-Switch™ Laparoscopic Instruments
Taiwan Surgical Corporation, TW
GEI
Jul 22, 2026K261179AlphaTriPart - Monopolar MIC Instruments
Gimmi GmbH, DE
GEI
Jul 13, 2026K253504Volnewmer™
Classys, Inc., KR
GEI
Jul 1, 2026K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (T
Olympus Medical Systems Corp., JP
GEI
Jun 29, 2026K253484LUTRONIC GENIUS
Cynosure Lutronic Technology Corporation, KR
GEI
Jun 29, 2026K251492Irrigation Tubing Bipolar Cord Set
New Deantronics Taiwan , Ltd., TW
GEI
Jun 18, 2026K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
Stryker Sustainability Solutions
GEI
Jun 17, 2026K253634CoolSeal Generator® (CSL-200-90)
Hologic, Inc.
GEI
Jun 16, 2026K261833NEUROMARK System (NMK00301)
Neurent Medical , Ltd., IE
GEI
Jun 9, 2026K253165LAP-iX2N
Sejong Medical Co., Ltd., KR
GEI
Jun 5, 2026K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
Medtronic Sofamor Danek USA, Inc.
GEI
Jun 2, 2026K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
F Care Systems USA, LLC
GEI
Jun 2, 2026K253803MILAN System
Lumenis Be, Ltd., IL
GEI
May 29, 2026K261202ENTire IRE System
Entire Medical , Ltd., IL
GEI
May 26, 2026K252833VIVA combo RF System
Starmed Co., Ltd., KR
GEI
May 20, 2026K253134LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
Lagis Enterprise Co., Ltd., TW
GEI
May 18, 2026K260522RhinAer+ Stylus
Aerin Medical, Inc.
GEI
Apr 10, 2026K253917ARION ARC System
Plasma Surgical, Inc.
GEI
Apr 10, 2026K253777Ascblue (8010)
Ascblue Corporation
GEI
Apr 7, 2026K260466Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Elec
Zhejiang shuyou Surgical Instrument Co., Ltd., CN
GEI
Apr 6, 2026K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
Hironic Co., Ltd., KR
GEI
Apr 1, 2026K253405Prana System
Prana Surgical
GEI
Mar 30, 2026K254122FLOW FLEXTEND Wand (72290039)
ArthroCare Corporation
GEI
Mar 27, 2026K260255AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
Aventix Medical, Inc.
GEI
Mar 25, 2026K253680LYNX COBLATION Laryngeal Wand (72290254)
ArthroCare Corporation
GEI
Mar 17, 2026K253750BTL-785NEH
BTL Industries, Inc.
GEI
Mar 2, 2026K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
Gyrus Acmi, Inc.
GEI
Feb 24, 2026K260287SP Electrocautery Device (SP20)
Single Pass, Inc.
GEI
Feb 11, 2026K251813CURIS II RF Generator (REF 360100-05)
Sutter Medizintechnik GmbH, DE
GEI
Feb 6, 2026K251836Dermatrix Duo
Shenzhen Gsd Technology Co., Ltd., CN
GEI
Jan 30, 2026K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
Shenzhen Peninsula Medical Group, CN
GEI
Jan 27, 2026K254220Reusable 3 Button Fingerswitch Wand
Soniquence, LLC
GEI
Jan 27, 2026K251435InbellaIgnite RF System
Inbella Medical, Inc., CA
GEI
Jan 15, 2026K251254Ignite RF System
InMode , Ltd., IL
GEI
Jan 14, 2026K251996ENTire IRE System
Entire Medical , Ltd., IL
GEI
Jan 12, 2026K251988Boston iFace (Boston iFace)
Boston Aesthetics, Inc.
GEI
Dec 18, 2025K253915MOVIVA® Hybrid Ablation Probe
Erbe Elektromedizin GmbH, DE
GEI
Nov 24, 2025K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
F Care Systems USA, LLC
GEI
Nov 17, 2025K251566TS-RF Generator (STS10)
Starmed Co., Ltd., KR
GEI
Nov 6, 2025K252845Venus Nova (FP-2001)
Venus Concept, Inc.
GEI
Nov 4, 2025K252740Voyant® Open Fusion Device (EB240/Open Fusion)
Applied Medical Resources Corp.
GEI
Oct 31, 2025K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
Applied Medical Resources Corporation
GEI
Oct 28, 2025K250275PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
Baylis Medical Technologies, Inc., CA
GEI

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