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FDA 510(k)

GELSPHERES EMBOLIC AGENT

K-Number: K023089 · 2002-12-16

ApplicantBiocure, Inc.
Decision Date2002-12-16
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GELSPHERES EMBOLIC AGENT is the device name listed in this FDA 510(k) record. The listed applicant is Biocure, Inc.. It received FDA 510(k) clearance on 2002-12-16 under 510(k) number K023089. 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 EMBOLIC AGENT?

GELSPHERES EMBOLIC AGENT is a medical device that received FDA 510(k) clearance on 2002-12-16. The listed applicant is Biocure, Inc.. The 510(k) number is K023089.

When did GELSPHERES EMBOLIC AGENT receive FDA 510(k) clearance?

GELSPHERES EMBOLIC AGENT received FDA 510(k) clearance on 2002-12-16, under 510(k) number K023089.

Who is the listed applicant for GELSPHERES EMBOLIC AGENT?

The FDA 510(k) record lists Biocure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GELSPHERES EMBOLIC AGENT?

The FDA product code for GELSPHERES EMBOLIC AGENT is HCG.

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Other records listing Biocure, Inc. as applicant

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.

K073663GELSPRAY WOUND DRESSING

Related Devices (Code: HCG)

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.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular

Official Source

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