510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Fannin (UK) Limited

Clevedon North Somerset, GB

FANNIN (UK) LIMITED appears in FDA device records in Clevedon North Somerset, GB. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to Fannin (UK) Limited carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Espiner Medical Limited510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Fannin (UK) Limited in 2011.

Clearances by year, as a table
510(k) clearance decisions for Fannin (UK) Limited, by decision year
YearClearances
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K111845THE ESPINER SAC OR E SACGCJSubstantially Equivalent

Registered establishments

FDA registered establishments for Fannin (UK) Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30124536733012453673FANNIN (UK) LIMITEDWestminster Industrial Estate, Repton Road, Measham, Swadlincote Derbyshire DE12 8DT GB2026
30092314023009231402Fannin UK LtdYeo Bank 3, Kenn Road, Clevedon North Somerset BS21 6TH GB2026

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
RecallProductReasonClassificationInitiatedStatus
Z-0444-2019Espiner 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 incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000mlClass IITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain