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FDA 510(k)

EmboCube Embolization Gelatin

K-Number: K181021 · 2018-09-27

ApplicantBiosphere Medical, S.A.
Decision Date2018-09-27
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EmboCube Embolization Gelatin is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical, S.A.. It received FDA 510(k) clearance on 2018-09-27 under 510(k) number K181021. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EmboCube Embolization Gelatin?

EmboCube Embolization Gelatin is a medical device that received FDA 510(k) clearance on 2018-09-27. The listed applicant is Biosphere Medical, S.A.. The 510(k) number is K181021.

When did EmboCube Embolization Gelatin receive FDA 510(k) clearance?

EmboCube Embolization Gelatin received FDA 510(k) clearance on 2018-09-27, under 510(k) number K181021.

Who is the listed applicant for EmboCube Embolization Gelatin?

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

What is the FDA product code for EmboCube Embolization Gelatin?

The FDA product code for EmboCube Embolization Gelatin is KRD.

Other records listing Biosphere Medical, S.A. 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.

K250971Embosphere MicrospheresK192480Torpedo Gelatin FoamK183120EmboCube Embolization GelatinK183578Torpedo Gelatin FoamK181300Embosphere MicrospheresK172372QuadraSphere Microspheres

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Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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.

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