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FDA 510(k)

EMBOGOLD MICROSPHERE

K-Number: K010026 · 2001-06-21

ApplicantBiosphere Medical, Inc.
Decision Date2001-06-21
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMBOGOLD MICROSPHERE is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical, Inc.. It received FDA 510(k) clearance on 2001-06-21 under 510(k) number K010026. 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 EMBOGOLD MICROSPHERE?

EMBOGOLD MICROSPHERE is a medical device that received FDA 510(k) clearance on 2001-06-21. The listed applicant is Biosphere Medical, Inc.. The 510(k) number is K010026.

When did EMBOGOLD MICROSPHERE receive FDA 510(k) clearance?

EMBOGOLD MICROSPHERE received FDA 510(k) clearance on 2001-06-21, under 510(k) number K010026.

Who is the listed applicant for EMBOGOLD MICROSPHERE?

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

What is the FDA product code for EMBOGOLD MICROSPHERE?

The FDA product code for EMBOGOLD MICROSPHERE is HCG.

Related Clinical Trials

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Other records listing Biosphere Medical, 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.

K113822QUADRASPHERE 30 TO 60K052742HEPASPHERE MICROSPHERESK062126EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135K061171SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XXK021397EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION

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

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