FDA.reportPublic FDA data

VFS1 Generator Main Unit

Primary DI
00873263008157
Brand
VFS1 Generator Main Unit
Company
FHC, INC.
Model
C0840-00815
Catalog number
C0840
Device description
VFS1 Bipolar Electrosurgical Generator, 1 x
Published
2020-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200169000VFS1 Bipolar Electrosurgical GeneratorFHC, Inc.2020-05-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00873263008157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00873263008157008732630081578732630081570873263008157

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure500 KiloPascal1060 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)326-2905fhcinc@fh-co.com

Regulatory Flags#

DUNS number
108179458
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00873263007693microTargeting™ Insertion Tube66-IT-IT2P-0076966-IT-IT2P2026-05-08
00873263007785microTargeting™ Insertion Tube66-IT(IT2)-0077866-IT(IT2)2026-05-08
00873263007792microTargeting™ Insertion Tube66-PT(IT2)-0077966-PT(IT2)2026-05-08
00873263003046WayPoint™ Surgical Kit66-WP-SKS-0030466-WP-SKS2016-09-17
00873263003190WayPoint™ Implant Kit66-WP-IKS-0031966-WP-IKS2016-09-17
00873263009604microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
00873263009468microTargeting™ PlatformMP-KIT-P-VO-00946MP-KIT-P-VO2026-03-16
00873263009475microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
10873263009625microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263009611microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
10873263009618microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
00873263009628microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263002254STar™ Drive XL Frame Adapter70-FA-RD-XL-0022570-FA-RD-XL2016-09-17
00873263002285STar™ Drive XL Frame Adapter70-FA-LX-XL-0022870-FA-LX-XL2016-09-17
00873263002322STar™ Drive Frame Adapter70-FA-LX-0023270-FA-LX2016-09-17
00873263002360microTargeting™ STar™ Array Insertion Tube Extractor70-CN-ET-0023670-CN-ET2016-09-17
00873263006047WayPoint™ Entry Offset Mounting Hub66-MP-EH-0060466-MP-EH2018-04-01
00873263006184STar™ Drive Frame Adapter70-FA-GP-0061870-FA-GP2017-08-29
00873263008546STar™ Drive Frame Adapter70-FA-LX-NN-0085470-FA-LX-NN2022-09-26
00873263009581STar™ Drive Frame Adapter70-FA-LS-0095870-FA-LS2026-01-25

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Primary DI, Brand, Company table
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B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
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07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
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