FDA.reportPublic FDA data

Electrosurgical Generator

Primary DI
00868260000228
Brand
Electrosurgical Generator
Company
CLEARSTREAM TECHNOLOGIES LIMITED
Model
ESU-1
Catalog number
ESU-1
Device description
Electrosurgical Generator
Published
2018-08-20
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
K162656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162656000ESU-1 Electrosurgical GeneratorTva Medical, Inc.2016-11-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868260000228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868260000228008682600002288682600002280868260000228

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(512)582-2460medical.services@crbard.com
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
989214291
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741184802Halo One™ Thin-Walled Guiding SheathHLO41018FHHLO41018FH2020-04-27
00801741184819Halo One™ Thin-Walled Guiding SheathHLO41035FHHLO41035FH2020-04-27
00801741184833Halo One™ Thin-Walled Guiding SheathHLO51018FHHLO51018FH2020-04-27
00801741184840Halo One™ Thin-Walled Guiding SheathHLO51035FHHLO51035FH2020-04-27
00801741184864Halo One™ Thin-Walled Guiding SheathHLO61035FHHLO61035FH2020-04-27
00801741223778Halo One Thin-Walled Guiding SheathHLO41018FHKHLO41018FHK2021-12-14
00801741223785Halo One Thin-Walled Guiding SheathHLO41035FHKHLO41035FHK2021-12-14
00801741223815Halo One Thin-Walled Guiding SheathHLO51018FHKHLO51018FHK2021-12-14
00801741223822Halo One Thin-Walled Guiding SheathHLO51035FHKHLO51035FHK2021-12-14
00801741223853Halo One Thin-Walled Guiding SheathHLO61035FHKHLO61035FHK2021-12-14
00801741223907Halo One Thin-Walled Guiding SheathHLO61018FHKHLO61018FHK2021-12-14
00801741184826Halo One™ Thin-Walled Guiding SheathHLO42535HHLO42535H2020-04-27
00801741184857Halo One™ Thin-Walled Guiding SheathHLO52535HHLO52535H2020-04-27
00801741184871Halo One™ Thin-Walled Guiding SheathHLO62535HHLO62535H2020-04-27
00801741223792Halo One Thin-Walled Guiding SheathHLO42518HKHLO42518HK2021-12-14
00801741223808Halo One Thin-Walled Guiding SheathHLO42535HKHLO42535HK2021-12-14
00801741223839Halo One Thin-Walled Guiding SheathHLO52518HKHLO52518HK2021-12-14
00801741223846Halo One Thin-Walled Guiding SheathHLO52535HKHLO52535HK2021-12-14
00801741223860Halo One Thin-Walled Guiding SheathHLO62535HKHLO62535HK2021-12-14
00801741223914Halo One Thin-Walled Guiding SheathHLO62518HKHLO62518HK2021-12-14

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Primary DI, Brand, Company table
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B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
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08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
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