FDA 510(k)

OBSIDIO Conformable Embolic (M0013972101010)

K-Number: K253376 · 2025-10-30

Decision Date2025-10-30

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OBSIDIO Conformable Embolic (M0013972101010) is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-10-30 under approval number K253376. 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 OBSIDIO Conformable Embolic (M0013972101010)?

OBSIDIO Conformable Embolic (M0013972101010) is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Boston Scientific Corporation. The 510(k) number is K253376.

When was OBSIDIO Conformable Embolic (M0013972101010) approved by the FDA?

OBSIDIO Conformable Embolic (M0013972101010) received FDA 510(k) clearance on 2025-10-30, under approval number K253376.

What company makes OBSIDIO Conformable Embolic (M0013972101010)?

OBSIDIO Conformable Embolic (M0013972101010) is manufactured by Boston Scientific Corporation.

What is the FDA product code for OBSIDIO Conformable Embolic (M0013972101010)?

The FDA product code for OBSIDIO Conformable Embolic (M0013972101010) 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.