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FDA 510(k)

PRELOADED TISSUE MARKER DEVICE

K-Number: K100994 · 2010-04-30

ApplicantCarbon Medical Technologies, Inc.
Decision Date2010-04-30
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRELOADED TISSUE MARKER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2010-04-30 under 510(k) number K100994. 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 PRELOADED TISSUE MARKER DEVICE?

PRELOADED TISSUE MARKER DEVICE is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Carbon Medical Technologies, Inc.. The 510(k) number is K100994.

When did PRELOADED TISSUE MARKER DEVICE receive FDA 510(k) clearance?

PRELOADED TISSUE MARKER DEVICE received FDA 510(k) clearance on 2010-04-30, under 510(k) number K100994.

Who is the listed applicant for PRELOADED TISSUE MARKER DEVICE?

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

What is the FDA product code for PRELOADED TISSUE MARKER DEVICE?

The FDA product code for PRELOADED TISSUE MARKER DEVICE is NEU.

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Other records listing Carbon Medical Technologies, 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.

K253598InjecSURE Injection SystemK251748MammoSTAR Biopsy Site IdentifierK211590Fiducial MarkerK172227Endoscopic Injection NeedleK132708BIOMARC FIDUCIAL MARKERK130678BIOMARC GOLD FIDUCIAL MARKER

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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.

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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