BIOCOMPATIBLES U.K. Limited, a BTG Company
Farnham, SURREY ENGLAND Surrey, GB
BIOCOMPATIBLES U.K. LIMITED, a BTG Company appears in FDA device records in Farnham, SURREY ENGLAND Surrey, GB. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to BIOCOMPATIBLES U.K. Limited, a BTG Company 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.
- Biocompatibles UK Limited510(k), enforcement report, recall
510(k) clearance history
FDA records hold 7 510(k) clearances for BIOCOMPATIBLES U.K. Limited, a BTG Company between 2004 and 2016. The busiest year on record is 2004, with 2. The most recent is 2016, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2008 | 1 |
| 2010 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162373 | LC Bead LUMI | KRD | Substantially Equivalent | |
| K150876 | Bead Block | KRD | Substantially Equivalent | |
| K152157 | LC Bead LUMI | KRD | Substantially Equivalent | |
| K094018 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | HCG | Substantially Equivalent | |
| K083091 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | KRD | Substantially Equivalent | |
| K042231 | GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES | HCG | Substantially Equivalent | |
| K033761 | GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES | HCG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002124543 | 3002124543 | BIOCOMPATIBLES U.K. LIMITED, a BTG Company | Chapman House, Weydon Lane, Farnham, SURREY ENGLAND GU9 8QL GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0078-2017 | TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters. | One mislabeled dose of TheraSphere Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). The product ws labeled as 10 GBq and the actual does was 5 GBq. | Class II | Terminated |
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets BIOCOMPATIBLES U.K. Limited, a BTG Company edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain