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FDA 510(k)

SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER

K-Number: K120796 · 2012-10-26

ApplicantSuperdimension, Inc.
Decision Date2012-10-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Superdimension, Inc.. It received FDA 510(k) clearance on 2012-10-26 under 510(k) number K120796. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER?

SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER is a medical device that received FDA 510(k) clearance on 2012-10-26. The listed applicant is Superdimension, Inc.. The 510(k) number is K120796.

When did SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER receive FDA 510(k) clearance?

SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER received FDA 510(k) clearance on 2012-10-26, under 510(k) number K120796.

Who is the listed applicant for SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER?

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

What is the FDA product code for SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER?

The FDA product code for SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER is JAK.

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 Superdimension, 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.

K110093SUPERDIMENSION MARKER DELIVERY KIT

Related Devices (Code: JAK)

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

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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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