Data / Medical devices / United Kingdom / Surgical Innovations Ltd
Surgical Innovations Ltd: FDA-registered device maker in Leeds, United Kingdom, 8 510(k) clearances
Surgical Innovations Ltd is registered with the FDA (registration 9680952) in Leeds, United Kingdom. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 18, 2021. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680952
- FEI number
- 3002808173
- Address
- Clayton Wood House 6 Clayton Wood Bank, Leeds, United Kingdom, LS16 6QZ
- Owner or operator
- SURGICAL INNOVATIONS PLC (9008575)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 30, 2007
- Registered through
- 2026
- Brand names listed
- FastClamp/TableClamp, LIQUIFIX FIX8, Logi Single Use Inserts, LogiFlex Gastric Band Positioning Device, Logic Reusable Handles & Inserts, Pretzelflex Retractor Reusable, YelloPort Elite Hasson Adaptors, YelloPort Elite Reusable Cannula and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Tissue Adhesive Internal Use | PLJ | 3 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2021 | K210495 | Port Access System | GCJ | Substantially Equivalent | Surgical Innovations Limited | accessdata.fda.gov |
| April 29, 2019 | K190592 | YelloPort Elite Port Access System | GCJ | Substantially Equivalent | Surgical Innovations Limited | accessdata.fda.gov |
| January 17, 2013 | K123110 | PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 | GCJ | Substantially Equivalent | Surgical Innovations Plc | accessdata.fda.gov |
| January 26, 2012 | K111986 | LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM | GEI | Substantially Equivalent | Surgical Innovations Plc | accessdata.fda.gov |
| September 7, 2010 | K100442 | FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM | GCJ | Substantially Equivalent | Surgical Innovations Group Plc | accessdata.fda.gov |
| July 15, 2010 | K100109 | LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE | GCJ | Substantially Equivalent | Surgical Innovations Plc | accessdata.fda.gov |
| March 28, 2007 | K070712 | MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM | GCJ | Substantially Equivalent | Surgical Innovations Group Plc | accessdata.fda.gov |
| December 1, 2006 | K063485 | LOGIC LAPAROSCOPIC SCISSORS | GEI | Substantially Equivalent | Surgical Innovations Plc | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 28, 2023 | 92114 | Class II | Ongoing | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar,, Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | accessdata.fda.gov |
| June 2, 2022 | 90447 | Class II | Completed | 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. | accessdata.fda.gov |
| January 20, 2022 | 90801 | Class II | Ongoing | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated May 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.