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FDA 510(k)

Torpedo Gelatin Foam

K-Number: K183578 · 2019-06-18

ApplicantBiosphere Medical, S.A.
Decision Date2019-06-18
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Torpedo Gelatin Foam 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 2019-06-18 under 510(k) number K183578. 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 Torpedo Gelatin Foam?

Torpedo Gelatin Foam is a medical device that received FDA 510(k) clearance on 2019-06-18. The listed applicant is Biosphere Medical, S.A.. The 510(k) number is K183578.

When did Torpedo Gelatin Foam receive FDA 510(k) clearance?

Torpedo Gelatin Foam received FDA 510(k) clearance on 2019-06-18, under 510(k) number K183578.

Who is the listed applicant for Torpedo Gelatin Foam?

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 Torpedo Gelatin Foam?

The FDA product code for Torpedo Gelatin Foam 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 GelatinK181021EmboCube Embolization GelatinK181300Embosphere MicrospheresK172372QuadraSphere Microspheres

View all 7 devices →

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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