FDA 510(k)

GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES

K-Number: K042231 · 2004-11-12

Decision Date2004-11-12

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles UK Limited. It received FDA 510(k) clearance on 2004-11-12 under 510(k) number K042231. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES?

GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES is a medical device that received FDA 510(k) clearance on 2004-11-12. The listed applicant is Biocompatibles UK Limited. The 510(k) number is K042231.

When did GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES receive FDA 510(k) clearance?

GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES received FDA 510(k) clearance on 2004-11-12, under 510(k) number K042231.

Who is the listed applicant for GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES?

The FDA 510(k) record lists Biocompatibles UK Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES?

The FDA product code for GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES is HCG.

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Other records listing Biocompatibles UK Limited as applicant

K162373LC Bead LUMI K094018LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES K083091LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES K033761GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES

Related Devices (Code: HCG)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.