FDA.reportPublic FDA data

Endoplus

Primary DI
00817401028447
Brand
Endoplus
Company
Endoplus
Model
5365J
Device description
5mm Medium Curved Dissector Insert, Short Length
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K151567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151567000ENDOPLUS hand-held laparoscopic instrumentsEndoplus2015-12-23HFI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817401028447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817401028447008174010284478174010284470817401028447

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
794679167
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817401029147EndoplusE332RR-452026-05-13
00817401029154EndoplusE382RR-452026-05-13
00817401029130EndoplusE322S2026-02-06
00817401029123EndoplusE404RR2026-01-16
00817401029116EndoplusE404RR-452025-12-19
00817401029109EndoplusE356SL2025-04-10
00817401029093EndoplusE308RR-452025-03-14
00817401029079EndoplusE339SLR2024-12-13
00817401029086EndoplusE302R2024-12-13
00817401029062EndoplusE363RR-452024-11-21
00817401029048EndoplusE382MR2024-08-30
00817401029055EndoplusE382RR2024-08-30
00817401028614EndoplusE300DVR2024-04-30
00817401028621EndoplusE300DVR-452024-04-30
00817401028638EndoplusE307DVR2024-04-30
00817401028645EndoplusE307DVR-452024-04-30
00817401028652EndoplusE313DVR2024-04-30
00817401028669EndoplusE313DVR-452024-04-30
00817401028676EndoplusE317DVR2024-04-30
00817401028683EndoplusE317DVR-452024-04-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006143Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006150Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006167Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006174Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006181Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006198Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006211Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006242Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006266Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006273Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006310Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006341Triple Footswitch & CableELLIQUENCE, LLCGEI2026-06-02
00846338007133Trigger-Flex Quad Pro Bipolar SystemELLIQUENCE, LLCGEI2026-06-02
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-02
00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004729Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004736Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01