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

K210942MicroFrance Monopolar And Bipolar Electrosurgical InstrumentsIntegra MicroFrance
K210526Medline Cautery Tip CleanerMedline Industries, Inc.
K210338Edge Insulated Blade ElectrodeCovidien LLC
K203795Star RF Electrode, VIVA RF ElectrodeSTARmed Co., Ltd.
K203640CoolSeal RevealBolder Surgical, LLC
K203580ArtiSential Laparoscopic Instruments-ElectrodesLivsMed Inc.
K203494Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies LTD
K203461Aesculap Caiman 12 Seal And Cut Technology SystemAesculap Inc.
K203299CellFX SystemPulse Biosciences, Inc.
K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH
K203183CoolSeal Trinity (30 Cm Shaft, 37 Cm Shaft, And 44 Cm Shaft)Bolder Surgical, LLC
K202988Tixel SystemNovoxel Ltd.
K202938Aesculap Caiman 5 Seal And Cut Technology SystemAesculap Inc.
K202415VirtueRFShenB Co Ltd
K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 Cm Shaft)/CSL-TR105-30, CoolSeal Trinity (37 Cm Shaft)/CSL-TR105-37, CoolSeal Trinity (44 Cm Shaft)/CSL-TR105-44, CoolSeal Mini (20cm Shaft)/CSL-MN103-20Bolder Surgical, 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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