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 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž
Electrosurgical, Cutting & Coagulation & Accessories [29857]21 CFR §878.4400 ๐Ÿ”Ž

Pre-market Notifications for GEI

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
K221907RhinAerยฎ Stylus (FG1393)Aerin Medical Inc.
K221407TruSculpt IDCutera Inc.
K220970Renuvion APR HandpieceApyx Medical Corporation(formerly Bovie Medical Corporation)
K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)Stryker Sustainability Solutions
K220384ArtiSential Laparoscopic Instruments-ElectrodesLivsMed Inc.
K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen Ltd.
K220071Soniquence Reusable Neutral PlateSoniquence, LLC
K213814Viveve 2.0 SystemViveve, Inc.
K213696ETHICON Megadyne Electrosurgical GeneratorMegadyne Medical Products, Inc.
K213612SYLFIRM XVIOL Co., Ltd.
K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify CartConMed Corporation
K213344BTL-899ABTL Industries Inc.
K213317ShinEvac Smoke Evacuation PencilShining World Health Care Co., Ltd.
K213127ReNew Disposable Scissor TipsMicroline Surgical, Inc.

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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