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FDA 510(k)

BIOPSY SITE MARKER

K-Number: K011402 · 2001-07-16

ApplicantSenorx, Inc.
Decision Date2001-07-16
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOPSY SITE 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 2001-07-16 under 510(k) number K011402. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY SITE MARKER?

BIOPSY SITE MARKER is a medical device that received FDA 510(k) clearance on 2001-07-16. The listed applicant is Senorx, Inc.. The 510(k) number is K011402.

When did BIOPSY SITE MARKER receive FDA 510(k) clearance?

BIOPSY SITE MARKER received FDA 510(k) clearance on 2001-07-16, under 510(k) number K011402.

Who is the listed applicant for BIOPSY SITE 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 BIOPSY SITE MARKER?

The FDA product code for BIOPSY SITE MARKER is FZP.

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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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