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 the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical ULC. It received FDA 510(k) clearance on 2024-12-27 under 510(k) 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. The listed applicant is 7D Surgical ULC. The 510(k) number is K242480.

When did FLASH EVD System (10-0002) receive FDA 510(k) clearance?

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

Who is the listed applicant for FLASH EVD System (10-0002)?

The FDA 510(k) record lists 7D Surgical ULC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners K250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

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.