Pounce(TM) Sheath
K-Number: K252227 · 2025-09-24
ApplicantSurmodics,Inc.
Decision Date2025-09-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Pounce(TM) Sheath is a medical device manufactured by Surmodics,Inc.. It received FDA 510(k) clearance on 2025-09-24 under approval number K252227. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pounce(TM) Sheath?
Pounce(TM) Sheath is a medical device that received FDA 510(k) clearance on 2025-09-24. It is manufactured by Surmodics,Inc.. The 510(k) number is K252227.
When was Pounce(TM) Sheath approved by the FDA?
Pounce(TM) Sheath received FDA 510(k) clearance on 2025-09-24, under approval number K252227.
What company makes Pounce(TM) Sheath?
Pounce(TM) Sheath is manufactured by Surmodics,Inc..
What is the FDA product code for Pounce(TM) Sheath?
The FDA product code for Pounce(TM) Sheath is DYB.
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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.