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FDA 510(k)

SUPERDIMENSION MARKER DELIVERY KIT

K-Number: K110093 · 2011-02-11

ApplicantSuperdimension, Inc.
Decision Date2011-02-11
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUPERDIMENSION MARKER DELIVERY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Superdimension, Inc.. It received FDA 510(k) clearance on 2011-02-11 under 510(k) number K110093. 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 MARKER DELIVERY KIT?

SUPERDIMENSION MARKER DELIVERY KIT is a medical device that received FDA 510(k) clearance on 2011-02-11. The listed applicant is Superdimension, Inc.. The 510(k) number is K110093.

When did SUPERDIMENSION MARKER DELIVERY KIT receive FDA 510(k) clearance?

SUPERDIMENSION MARKER DELIVERY KIT received FDA 510(k) clearance on 2011-02-11, under 510(k) number K110093.

Who is the listed applicant for SUPERDIMENSION MARKER DELIVERY KIT?

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 MARKER DELIVERY KIT?

The FDA product code for SUPERDIMENSION MARKER DELIVERY KIT 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.

K120796SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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