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FDA 510(k)

NTERO RF SLEEVE

K-Number: K992572 · 1999-09-24

ApplicantNtero Surgical, Inc.
Decision Date1999-09-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NTERO RF SLEEVE 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 1999-09-24 under 510(k) number K992572. 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 RF SLEEVE?

NTERO RF SLEEVE is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Ntero Surgical, Inc.. The 510(k) number is K992572.

When did NTERO RF SLEEVE receive FDA 510(k) clearance?

NTERO RF SLEEVE received FDA 510(k) clearance on 1999-09-24, under 510(k) number K992572.

Who is the listed applicant for NTERO RF SLEEVE?

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 RF SLEEVE?

The FDA product code for NTERO RF SLEEVE 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 SYSTEMK010815NTERO NOMAD SYSTEM

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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