Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680952

FEI Number

3002808173

Entity Name

SURGICAL INNOVATIONS LTD

City/State/Country

LEEDS, GB

Establishment Address

CLAYTON WOOD HOUSE, 6 CLAYTON WOOD BANK, LEEDS LS16 6QZ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SURGICAL INNOVATIONS PLC (Owner Number: 9008575)

Owner / Operator Contact Address

CLAYTON WOOD HOUSE,, 6 CLAYTON WOOD BANK, LEEDS, GB-NOTA LS16 6QZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123110

PMA Number

N/A

All Registered Proprietary Names

LIQUIFIX FIX8 YelloPort Plus Reusable Cannula YelloPort Plus Reusable Caps YelloPort Plus Single Use Valves YelloPort Plus Reusable Trocar LogiFlex Gastric Band Positioning Device FastClamp/TableClamp Logic Reusable Handles & Inserts Pretzelflex Retractor Reusable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLJ	Tissue Adhesive Internal Use	General, Plastic Surgery	Class 3	878.4010	2023-06-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-05-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-08-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-09-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-02-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-23

Official Correspondent

No official correspondent registered.

US Agent Details

Edwin Lindsay Business: RAF Solutions INC Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

SURGICAL INNOVATIONS PLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE
9617175	Advanced Medical Solutions Limited	PLYMOUTH Devon, GB
3016804805	CLEARCAM	Austin, TX, US
3011936016	Sony Olympus Medical Solutions Inc.	Hachioji-shi Tokyo, JP
3015335150	VERNACARE LTD.	Chorley Lancashire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680952. Last updated year: 2026. Please use registration number 9680952 when referencing this establishment in official correspondence.