Surgical Innovations Ltd

LEEDS Leeds, GB

SURGICAL INNOVATIONS LTD appears in FDA device records in LEEDS Leeds, GB. FDA records list 12 510(k) clearances between 1991-10-28 and 2021-06-18, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 5 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 12
PMA records: 0
Recall records: 5
Registered establishments: 1

510(k) clearance history

FDA records hold 12 510(k) clearances for Surgical Innovations Ltd between 1991 and 2021. The busiest year on record is 1994, with 2. The most recent is 2021, with 1.

Clearances by year, as a table

510(k) clearance decisions for Surgical Innovations Ltd, by decision year
Year	Clearances
1991	1
1994	2
1996	1
1997	1
2006	1
2010	1
2012	2
2013	1
2019	1
2021	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K210495	Port Access System	GCJ	Substantially Equivalent	2021-06-18
K190592	YelloPort Elite Port Access System	GCJ	Substantially Equivalent	2019-04-29
K123110	PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301	GCJ	Substantially Equivalent	2013-01-17
K112659	SURGICAL RETRACTORS	GCJ	Substantially Equivalent	2012-03-09
K111986	LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM	GEI	Substantially Equivalent	2012-01-26
K100109	LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE	GCJ	Substantially Equivalent	2010-07-15
K063485	LOGIC LAPAROSCOPIC SCISSORS	GEI	Substantially Equivalent	2006-12-01
K955393	NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE	HIF	Substantially Equivalent	1997-01-09
K962193	PORTLAND TROCARS	GCJ	Substantially Equivalent	1996-08-28
K944292	SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE	OCW	Substantially Equivalent	1994-11-15
K934105	DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES	GAG	Substantially Equivalent	1994-03-28
K914098	LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR	GCJ	Substantially Equivalent	1991-10-28

Registered establishments

FDA registered establishments for Surgical Innovations Ltd, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9680952	3002808173	SURGICAL INNOVATIONS LTD	CLAYTON WOOD HOUSE, LEEDS LS16 6QZ GB	2026	GCJ GEI PLJ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1602-2023	YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR	Optical Trocars sterility assurance can not be guaranteed	Class II	2023-03-28	Open, Classified
Z-1601-2023	YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR	Optical Trocars sterility assurance can not be guaranteed	Class II	2023-03-28	Open, Classified
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.	Class II	2022-06-02	Completed
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.	Class II	2022-01-20	Open, Classified
Z-1852-2022	Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.	Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.	Class II	2022-01-20	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain