FDA 510(k)

GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES

K-Number: K033761 · 2004-02-04

Decision Date2004-02-04

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

GELSPHERES / BEADBLOCK 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 2004-02-04 under 510(k) number K033761. 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 / BEADBLOCK COMPRESSIBLE MICROSPHERES?

GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES is a medical device that received FDA 510(k) clearance on 2004-02-04. The listed applicant is Biocompatibles UK Limited. The 510(k) number is K033761.

When did GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES receive FDA 510(k) clearance?

GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES received FDA 510(k) clearance on 2004-02-04, under 510(k) number K033761.

Who is the listed applicant for GELSPHERES / BEADBLOCK 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 / BEADBLOCK COMPRESSIBLE MICROSPHERES?

The FDA product code for GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES is HCG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 K042231GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES

Related Devices (Code: HCG)

Official Source

View on FDA Database →

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