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FDA 510(k)

Tembo Embolic System

K-Number: K253677 · 2025-12-15

ApplicantInstylla, Inc.
Decision Date2025-12-15
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tembo Embolic System is a medical device manufactured by Instylla, Inc.. It received FDA 510(k) clearance on 2025-12-15 under approval number K253677. 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 Tembo Embolic System?

Tembo Embolic System is a medical device that received FDA 510(k) clearance on 2025-12-15. It is manufactured by Instylla, Inc.. The 510(k) number is K253677.

When was Tembo Embolic System approved by the FDA?

Tembo Embolic System received FDA 510(k) clearance on 2025-12-15, under approval number K253677.

What company makes Tembo Embolic System?

Tembo Embolic System is manufactured by Instylla, Inc..

What is the FDA product code for Tembo Embolic System?

The FDA product code for Tembo Embolic System 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.

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