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FDA 510(k)

PROSTATE TISSUE MARKER

K-Number: K081170 · 2008-05-28

ApplicantSenorx, Inc.
Decision Date2008-05-28
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROSTATE TISSUE MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K081170. 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 PROSTATE TISSUE MARKER?

PROSTATE TISSUE MARKER is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is Senorx, Inc.. The 510(k) number is K081170.

When did PROSTATE TISSUE MARKER receive FDA 510(k) clearance?

PROSTATE TISSUE MARKER received FDA 510(k) clearance on 2008-05-28, under 510(k) number K081170.

Who is the listed applicant for PROSTATE TISSUE MARKER?

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 PROSTATE TISSUE MARKER?

The FDA product code for PROSTATE TISSUE MARKER is NEU.

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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.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

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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