Electrosurgical, Cutting & Coagulation & Accessories

Product Code: GEI

General & Plastic Surgery Microwave Medical Products

Definition: Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www. Gpo. Gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007. Pdf).

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4400


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as GEI

5648Electrosurgical, Cutting & Coagulation & AccessoriesElectrosurgical Cutting And Coagulation Device And Accessories.

Total Product Life Cycle (TPLC) Devices

5648Electrosurgical, Cutting & Coagulation & AccessoriesElectrosurgical Cutting And Coagulation Device And Accessories.

FDA Consensus Standards

Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 🔎

Pre-market Notifications for GEI

K223292TempSure SystemCynosure LLC
K223110TruSculpt IDCutera Inc.
K222793WavelinQ™ GeneratorC.R. Bard, Inc.
K222429Ellusa Reusable Bipolar CableEllusa, LLC
K222425Ellusa Reusable Neutral PlatesEllusa, LLC
K222284Voyant Maryland Fusion Device With Single-Step Activation (EB212, EB213, EB214)Applied Medical Resources Corporation
K222075CellFX SystemPulse Biosciences, Inc.
K222032NEUROMARK SystemNeurent Medical
K221989The OligioWON TECH Co., Ltd.
K221945Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm X 160 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 Mm X 320 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 Mm X 230 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 Mm X 320 Cm, Beamer AVEO FILConmed Corporation
K221907RhinAer® Stylus (FG1393)Aerin Medical Inc.
K221830Apyx One ConsoleApyx Medical Corporation
K221815Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)Baisheng Medical Co., Ltd.
K221407TruSculpt IDCutera Inc.
K221277Mygen M-3004 RF Generator M-3004RF Medical Co., Ltd

Global Unique Device Identification Database

00501986000121Electrosurgical, Cutting & Coagulation & Accessories
10381780177340ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
10381780176985ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
30381780169356ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
30381780169349ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
30381780169332ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
10381780169321ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
30381780169318ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
30381780169301ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
10381780169291ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
30381780169288ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
30381780169271ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
10381780165842ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
10381780165835ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
10381780024989ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Maude Adverse Events

LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
LIGASURE IMPACTCOVIDIEN MFG DC BOULDER2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
ENSEAL G2 CURVED JAW 35CMETHICON ENDO-SURGERY, LLC.2020-03-31
ENSEAL 5MM ROUND TIP 35CMETHICON ENDO-SURGERY, LLC.2020-03-31
ENSEAL G2 CURVED JAW 35CMETHICON ENDO-SURGERY, LLC.2020-03-31
EB210, VOYANT 5MM FUSION 37CM, 6/BXAPPLIED MEDICAL RESOURCES2020-03-31
EB210, VOYANT 5MM FUSION 37CM, 6/BXAPPLIED MEDICAL RESOURCES2020-03-31
VALLEYLABCOVIDIEN MFG DC BOULDER2020-03-31
VAPR3 GENERATOR *EADEPUY MITEK LLC US2020-03-31
EB210, VOYANT 5MM FUSION 37CM, 6/BXAPPLIED MEDICAL RESOURCES2020-03-31
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE SOLYMPUS MEDICAL SYSTEMS CORP.2020-03-31
PLASMABLADE 3.0SMEDTRONIC ADVANCED ENERGY, LLC2020-03-31
VAPR VUE GENERATORDEPUY MITEK LLC US2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
RF 2 PROBES, MICRO-CLAWSTRYKER ENDOSCOPY-SAN JOSE2020-03-31
CAIMAN MARYLAND ARTICULATING D5/360MMAESCULAP AG2020-03-31
LIGASURECOVIDIEN LLC2020-03-31
LIGASURECOVIDIEN LLC2020-03-31
ENSEALETHICON ENDO-SURGERY, INC2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
ERBE APC 2ERBE ELEKTROMEDIZIN GMBH2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
EDGECOVIDIEN MFG DC BOULDER2020-03-31
EDGECOVIDIEN MFG DC BOULDER2020-03-31
SURGISTATCOVIDIEN MFG DC BOULDER2020-03-31
EMPRINTCOVIDIEN LP - SUPERDIMENSION INC2020-03-31
VALLEYLAB FT10COVIDIEN MFG DC BOULDER2020-03-31
LIGASURECOVIDIEN MFG DC BOULDER2020-03-31
VALLEYLABCOVIDIEN MFG DC BOULDER2020-03-30
VAPR VUE WIRELESS FOOTSWITCHDEPUY MITEK LLC US2020-03-30
LIGASURECOVIDIEN MEDICAL PRODUCTS2020-03-30
FORCE FXCOVIDIEN MFG DC BOULDER2020-03-30
LIGASURECOVIDIEN MFG DC BOULDER2020-03-30
LIGASURECOVIDIEN MFG DC BOULDER2020-03-30
ATR.UNI.FIX FORCEPS W/GROOVES D:5/310MMAESCULAP AG2020-03-30
LIGASURE IMPACTCOVIDIEN MFG DC BOULDER2020-03-30
ATR.UNI.FIX FORCEPS W/GROOVES D:5/310MMAESCULAP AG2020-03-30
MONOPOLAR HANDLE WITH RATCHETAESCULAP AG2020-03-30
SMOKE EVAC. PENCIL, PB, COATEDLINA MEDICAL APS2020-03-30
LIGASURECOVIDIEN LP2020-03-30
ULTRACLEAN 6IN. BLADE EXTENDED INSULATIONCONSOLIDATED MEDICAL EQUIPMENT2020-03-30
LIGASURECOVIDIEN LP2020-03-30
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE SOLYMPUS MEDICAL SYSTEMS CORP.2020-03-30
AMBIENT SUPER MULTIVAC 50 IFSARTHROCARE CORP.2020-03-29
SUPER TURBOVAC 90 ICWARTHROCARE CORP.2020-03-28
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.