FDA.reportPublic FDA data

YelloPort Plus - Laparoscopic Port Access System

Primary DI
05051986001920
Brand
YelloPort Plus - Laparoscopic Port Access System
Company
SURGICAL INNOVATIONS LIMITED
Model
YC0509510
Device description
5x95 Threaded Cannula
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070712000MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEMSurgical Innovations Group Plc2007-03-28GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051986001920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051986001920050519860019205051986001920

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
771051935
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051986013503YelloPort Elite - Laparoscopic Port Access SystemET05055092025-03-11
05051986013510YelloPort Elite - Laparoscopic Port Access SystemET05070092025-03-11
05051986013527YelloPort Elite - Laparoscopic Port Access SystemET05095092025-03-11
05051986013572YelloPort Elite - Laparoscopic Port Access SystemEC13075202024-08-29
05051986013589YelloPort Elite - Laparoscopic Port Access SystemEC13105202024-08-29
05051986013596YelloPort Elite - Laparoscopic Port Access SystemEC13150202024-08-29
05051986001357YelloPort PlusYA516STS2016-09-23
05051986001562YelloPort Elite - Laparoscopic Port Access SystemEA512US2020-10-08
05051986002323YelloPort Plus - Laparoscopic Port Access SystemYA03VSS022020-10-08
05051986012537YelloPort Plus - Laparoscopic Port Access SystemYA03VSS032020-10-08
05051986013077YelloPort Elite EA05XL2022-04-14
05051986000794YelloPort530004S2017-07-10
05051986000831YelloPort550004S2017-07-10
05051986000824YelloPort550004R2016-09-23
05051986001050YelloPort585021S2016-09-23
05051986002286YelloPort Plus - Laparoscopic Port Access SystemYA03VSS012016-09-23
05051986002347YelloPort Plus - Laparoscopic Port Access SystemYA05VSS012016-09-23
05051986002361YelloPort Plus - Laparoscopic Port Access SystemYA05VSS022016-09-23
05051986002385YelloPort Plus - Laparoscopic Port Access SystemYA05VSS032016-09-23
05051986002408YelloPort Plus - Laparoscopic Port Access SystemYA510STSA2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210372LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210518LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210587LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210877LaportSejong Medical Co., LtdGCJ2018-04-05
10886705030187NAMedos International SàrlGCJ2018-02-22