Gelspheres Microspheres and Bead Block Compressible Microspheres
FDA 510(k) K042231 · Biocompatibles UK Limited
510(k) numberK042231
Submission
- Device name
- Gelspheres Microspheres and Bead Block Compressible Microspheres
- Applicant
- Biocompatibles UK Limited
South West Ranches, FL, US - Received
- August 17, 2004
- Decision date
- November 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Gelspheres Microspheres and Bead Block Compressible Microspheres cleared by the FDA?
Gelspheres Microspheres and Bead Block Compressible Microspheres (K042231) received a 510(k) decision of Substantially Equivalent on November 12, 2004, 87 days after the submission was received.
What is the product code of K042231?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.