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FDA 510(k)

SECURMARK BIOPSY SITE MARKING SYSTEM

K-Number: K102608 · 2010-10-08

ApplicantSuros Surgical Systems, Inc. A Hologic Company
Decision Date2010-10-08
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SECURMARK BIOPSY SITE MARKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Suros Surgical Systems, Inc. A Hologic Company. It received FDA 510(k) clearance on 2010-10-08 under 510(k) number K102608. 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 SECURMARK BIOPSY SITE MARKING SYSTEM?

SECURMARK BIOPSY SITE MARKING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-08. The listed applicant is Suros Surgical Systems, Inc. A Hologic Company. The 510(k) number is K102608.

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

SECURMARK BIOPSY SITE MARKING SYSTEM received FDA 510(k) clearance on 2010-10-08, under 510(k) number K102608.

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

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

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

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

Related Clinical Trials

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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Other records listing Suros Surgical Systems, Inc. A Hologic Company as applicant

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.

K072913SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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