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FDA 510(k)

NTERO NOMAD SYSTEM

K-Number: K010815 · 2001-06-15

ApplicantNtero Surgical, Inc.
Decision Date2001-06-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NTERO NOMAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ntero Surgical, Inc.. It received FDA 510(k) clearance on 2001-06-15 under 510(k) number K010815. 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 NTERO NOMAD SYSTEM?

NTERO NOMAD SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-15. The listed applicant is Ntero Surgical, Inc.. The 510(k) number is K010815.

When did NTERO NOMAD SYSTEM receive FDA 510(k) clearance?

NTERO NOMAD SYSTEM received FDA 510(k) clearance on 2001-06-15, under 510(k) number K010815.

Who is the listed applicant for NTERO NOMAD SYSTEM?

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

What is the FDA product code for NTERO NOMAD SYSTEM?

The FDA product code for NTERO NOMAD SYSTEM 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 Ntero Surgical, 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.

K014251NTERO HOTROD SYSTEMK992572NTERO RF SLEEVE

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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