Data / Medical devices / United Kingdom / Fannin UK Ltd
Fannin UK Ltd: FDA-registered device maker in Clevedon North Somerset, United Kingdom, 1 510(k) clearance
Fannin UK Ltd is registered with the FDA (registration 3009231402) in Clevedon North Somerset, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 26, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009231402
- Address
- Yeo Bank 3, Kenn Road, Clevedon North Somerset, United Kingdom, BS21 6TH
- Owner or operator
- Fannin UK Ltd (10038678)
- Roles
- Manufacturer
- First device listed
- November 2, 2011
- Registered through
- 2026
- Brand names listed
- Espiner Tissue Retrieval System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | 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 |
|---|---|---|---|---|---|---|
| September 26, 2011 | K111845 | THE ESPINER SAC OR E SAC | GCJ | Substantially Equivalent | Espiner Medical Limited | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 20, 2018 | 81003 | Class II | Terminated | Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorpor | Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml | accessdata.fda.gov |
Compare with other makers
Updated September 26, 2011. 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.