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

K201212Voyant Open Fusion DeviceApplied Medical Resources Corp.
K201164Venus Viva MD DeviceVenus Concept USA Inc.
K201063DANNIK Disposable Monopolar Laparoscopic InstrumentDannik
K200947InMode System With The Morhpeus8 ApplicatorsInMode Ltd.
K200875ArtiSential Laparoscopic Instruments - ElectrodesLivsMed Inc.
K200841Harmonic 1100 Shears, 20cm Length, Harmonic 1100 36cm Length, Generator G11Ethicon Endo-Surgery, Llc
K200598Voyant Maryland Fusion DeviceApplied Medical Resources Corp.
K200559CarpXPAVmed, Inc.
K200501ArtiSential Laparoscopic Instrument-ElectrodesLivsMed Inc.
K200455Trigger Switch And CordNew Deantronics Taiwan, Ltd.
K200300VivAer StylusAerin Medical Inc
K200253Megadyne Telescoping Smoke Evacuation Pencil - 10ft Tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft Tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue DissectorEthicon Endo-Surgery
K200185SYLFIRM XViol Co., Ltd.
K200169VFS1 Bipolar Electrosurgical GeneratorFHC, Inc.
K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, Llc

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

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