FDA.reportPublic FDA data

Disposable Sheath

Primary DI
20815288010689
Brand
Disposable Sheath
Company
ENCISION, INC.
Model
ES0150-45
Catalog number
ES0150-45
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
K191612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191612000Encision AEM Monopolar Laparoscopic Instruments and AccessoriesEncision Incorporated2020-03-20GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815288010689PackageGS110In Commercial Distribution
10815288010682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081528801068920815288010689
1081528801068210815288010682

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system monitor/shieldA dedicated unit designed to interface with an electrosurgical system to help detect and manage high frequency leakage of current from active electrodes used in combination with endoscopes or other instruments during endoscopic procedures (especially laparoscopic).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
612250175
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815288014239AEM® Burn Protection System CableES6107+ES6107+2025-05-27
10815288014369Alligator Forcep, Ratcheting Handle With Rotation, 45cmEP3080-45RREP3080-45RR2025-03-03
10815288014376Curved Maryland Dissector, 23mm Jaw, Ratcheting Handle With Rotation, 45cmEP3410-45RREP3410-45RR2025-03-03
10815288014314Single Action Needle Holder, Ratcheting Handle, With Rotation, 35cmEP3700RREP3700RR2024-02-07
10815288014345Round Tip Allis Grasping Forcep, Ratcheting Handle, With Rotation, 35cmEP3100RREP3100RR2024-02-07
108152880117955mm Cobra Jaw Grasping Forcep, Ratcheting Handle, With RotationES0540RRES0540RR2017-12-27
10815288013799Fenestrating Grasping Forcep, 35cmEP3280RREP3280RR2017-11-22
10815288013805Allis Forcep, 35cmEP3000RREP3000RR2017-11-22
10815288013812Fenestrated Bowel Grasper, 35cm, 20mm JawEP3690RREP3690RR2017-12-18
10815288013829Traumatic Grasper, 35cmEP3020RREP3020RR2018-02-08
10815288014253Rounded Maryland DissectorES0586ES05862023-06-21
10815288014260Rounded Maryland DissectorES0586-45ES0586-452023-06-21
10815288010712AEM® Disposable Handswitching Handpiece with Rocker SwitchES1300ES13002016-08-31
10815288013324PowerGrip Instrument HandleBP7500BP75002016-08-31
10815288013386PowerGrip Instrument HandleBP7500BP75002016-08-31
10815288013898Bipolar Instrument Handle with LockBP7200LBP7200L2018-09-10
10815288010231AEM® HandleES8000ES80002016-08-31
10815288010248AEM® HandleES8000LES8000L2016-08-31
10815288010255AEM® Handle, HoodedES8000HES8000H2016-08-31
10815288010262AEM® Handle HoodedES8000HLES8000HL2016-08-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006266Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006310Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006341Triple Footswitch & CableELLIQUENCE, LLCGEI2026-06-02
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00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
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