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 a medical device manufactured by Biosphere Medical, S.A.. It received FDA 510(k) clearance on 2019-06-18 under approval 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. It is manufactured by Biosphere Medical, S.A.. The 510(k) number is K183578.
When was Torpedo Gelatin Foam approved by the FDA?
Torpedo Gelatin Foam received FDA 510(k) clearance on 2019-06-18, under approval number K183578.
What company makes Torpedo Gelatin Foam?
Torpedo Gelatin Foam is manufactured by Biosphere Medical, S.A..
What is the FDA product code for Torpedo Gelatin Foam?
The FDA product code for Torpedo Gelatin Foam is KRD.
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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.