FDA.reportPublic FDA data

YelloPort Plus

Primary DI
05051986004952
Brand
YelloPort Plus
Company
SURGICAL INNOVATIONS LIMITED
Model
YOI1210503
Device description
LAPAROSCOPIC PORT ACCESS SYSTEMOptical 12x105mm Pencil Point trocar Box of 20Laparoscopic trocar, reusable
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05051986004969PackageGS120Not in Commercial Distribution
05051986009797PackageGS16Not in Commercial Distribution
05051986004952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051986004969050519860049695051986004969
05051986009797050519860097975051986009797
05051986004952050519860049525051986004952

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, reusableA rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. 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
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08