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FDA 510(k)

GEL MARK IV

K-Number: K040706 · 2004-04-08

ApplicantSenorx, Inc.
Decision Date2004-04-08
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GEL MARK IV is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2004-04-08 under 510(k) number K040706. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEL MARK IV?

GEL MARK IV is a medical device that received FDA 510(k) clearance on 2004-04-08. The listed applicant is Senorx, Inc.. The 510(k) number is K040706.

When did GEL MARK IV receive FDA 510(k) clearance?

GEL MARK IV received FDA 510(k) clearance on 2004-04-08, under 510(k) number K040706.

Who is the listed applicant for GEL MARK IV?

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

What is the FDA product code for GEL MARK IV?

The FDA product code for GEL MARK IV is NEU.

Other records listing Senorx, Inc. as applicant

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Related Devices (Code: NEU)

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.

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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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