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FDA 510(k)

MIXED MEDIA MARKER

K-Number: K102506 · 2011-01-12

ApplicantCortex Manufacturing, Inc.
Decision Date2011-01-12
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIXED MEDIA MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Manufacturing, Inc.. It received FDA 510(k) clearance on 2011-01-12 under 510(k) number K102506. 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 MIXED MEDIA MARKER?

MIXED MEDIA MARKER is a medical device that received FDA 510(k) clearance on 2011-01-12. The listed applicant is Cortex Manufacturing, Inc.. The 510(k) number is K102506.

When did MIXED MEDIA MARKER receive FDA 510(k) clearance?

MIXED MEDIA MARKER received FDA 510(k) clearance on 2011-01-12, under 510(k) number K102506.

Who is the listed applicant for MIXED MEDIA MARKER?

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

What is the FDA product code for MIXED MEDIA MARKER?

The FDA product code for MIXED MEDIA MARKER is NEU.

Related Clinical Trials

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Other records listing Cortex Manufacturing, 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.

K100267FLEXIMARC, MODEL CM-0.9-2-10-GG-L

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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