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FDA 510(k)

E-VAC

K-Number: K073455 · 2008-03-25

ApplicantNew Leaf Medical, Inc.
Decision Date2008-03-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E-VAC is the device name listed in this FDA 510(k) record. The listed applicant is New Leaf Medical, Inc.. It received FDA 510(k) clearance on 2008-03-25 under 510(k) number K073455. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-VAC?

E-VAC is a medical device that received FDA 510(k) clearance on 2008-03-25. The listed applicant is New Leaf Medical, Inc.. The 510(k) number is K073455.

When did E-VAC receive FDA 510(k) clearance?

E-VAC received FDA 510(k) clearance on 2008-03-25, under 510(k) number K073455.

Who is the listed applicant for E-VAC?

The FDA 510(k) record lists New Leaf Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-VAC?

The FDA product code for E-VAC is GEI.

Other records listing New Leaf Medical, Inc. as applicant

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.

K061829ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

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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.

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