FDA 510(k)

FLASH EVD System (10-0002)

K-Number: K242480 · 2024-12-27

Decision Date2024-12-27

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

FLASH EVD System (10-0002) is a medical device manufactured by 7D Surgical ULC. It received FDA 510(k) clearance on 2024-12-27 under approval number K242480. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLASH EVD System (10-0002)?

FLASH EVD System (10-0002) is a medical device that received FDA 510(k) clearance on 2024-12-27. It is manufactured by 7D Surgical ULC. The 510(k) number is K242480.

When was FLASH EVD System (10-0002) approved by the FDA?

FLASH EVD System (10-0002) received FDA 510(k) clearance on 2024-12-27, under approval number K242480.

What company makes FLASH EVD System (10-0002)?

FLASH EVD System (10-0002) is manufactured by 7D Surgical ULC.

What is the FDA product code for FLASH EVD System (10-0002)?

The FDA product code for FLASH EVD System (10-0002) is HAW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.