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FDA 510(k)

GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP

K-Number: K080698 · 2008-03-31

ApplicantSenorx, Inc.
Decision Date2008-03-31
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2008-03-31 under 510(k) number K080698. 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 ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP?

GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP is a medical device that received FDA 510(k) clearance on 2008-03-31. The listed applicant is Senorx, Inc.. The 510(k) number is K080698.

When did GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP receive FDA 510(k) clearance?

GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP received FDA 510(k) clearance on 2008-03-31, under 510(k) number K080698.

Who is the listed applicant for GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP?

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 ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP?

The FDA product code for GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP is NEU.

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Related Devices (Code: NEU)

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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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