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FDA 510(k)

TISSUE SITE MARKING SYSTEM

K-Number: K062528 · 2007-01-26

ApplicantSuros Surgical Systems, Inc.
Decision Date2007-01-26
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TISSUE SITE MARKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Suros Surgical Systems, Inc.. It received FDA 510(k) clearance on 2007-01-26 under 510(k) number K062528. 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 TISSUE SITE MARKING SYSTEM?

TISSUE SITE MARKING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-26. The listed applicant is Suros Surgical Systems, Inc.. The 510(k) number is K062528.

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

TISSUE SITE MARKING SYSTEM received FDA 510(k) clearance on 2007-01-26, under 510(k) number K062528.

Who is the listed applicant for TISSUE SITE MARKING SYSTEM?

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

What is the FDA product code for TISSUE SITE MARKING SYSTEM?

The FDA product code for TISSUE 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. 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.

K042290VACUUM ASSISTED CORE BIOPSY DEVICEK034021VACUUM ASSISTED CORE BIOPSY DEVICE

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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