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FDA 510(k)

SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES

K-Number: K010710 · 2001-05-18

ApplicantSeedling Enterprises., LLC
Decision Date2001-05-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Seedling Enterprises., LLC. It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K010710. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES?

SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Seedling Enterprises., LLC. The 510(k) number is K010710.

When did SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES receive FDA 510(k) clearance?

SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010710.

Who is the listed applicant for SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES?

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

What is the FDA product code for SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES?

The FDA product code for SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES is GEI.

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 Seedling Enterprises., LLC 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.

K012033MULTIFUNCTION ENDOSCOPIC INSTRUMENTK002841COOL-TEC ELECTRODESK001723COOL-TEC ELECTRODES

Related Devices (Code: GEI)

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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