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FDA 510(k)

SECRMARK BIOPSY SITE MARKING SYSTEM

K-Number: K102768 · 2010-12-02

ApplicantHologic, Inc.
Decision Date2010-12-02
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SECRMARK BIOPSY SITE MARKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2010-12-02 under 510(k) number K102768. 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 SECRMARK BIOPSY SITE MARKING SYSTEM?

SECRMARK BIOPSY SITE MARKING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-02. The listed applicant is Hologic, Inc.. The 510(k) number is K102768.

When did SECRMARK BIOPSY SITE MARKING SYSTEM receive FDA 510(k) clearance?

SECRMARK BIOPSY SITE MARKING SYSTEM received FDA 510(k) clearance on 2010-12-02, under 510(k) number K102768.

Who is the listed applicant for SECRMARK BIOPSY SITE MARKING SYSTEM?

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

What is the FDA product code for SECRMARK BIOPSY SITE MARKING SYSTEM?

The FDA product code for SECRMARK BIOPSY SITE MARKING SYSTEM is NEU.

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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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