Surgical Innovations Limited

Code	Device name	Class	Specialty	Clearances	Most recent
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology, Urology	1	2021-06-18

Date	Severity	Status	Recall #	Product	Code	Reason
2023-03-28	Class II	Ongoing	Z-1602-2023	YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR	—	Optical Trocars sterility assurance can not be guaranteed
2023-03-28	Class II	Ongoing	Z-1601-2023	YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR	—	Optical Trocars sterility assurance can not be guaranteed
2022-06-02	Class II	Completed	Z-1396-2022	YelloPort Elite Universal Seal. For use in laparoscopic procedures.	—	There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
2022-01-20	Class II	Ongoing	Z-1853-2022	Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.	—	Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
2022-01-20	Class II	Ongoing	Z-1852-2022	Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. Fo…	—	Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Date	K-number	Device	Code	Class	Specialty
2021-06-18	K210495	Port Access System	GCJ	Class II	Gastroenterology, Urology

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