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FDA 510(k)

DISPOSABLE STIMULATING ELECTRODE

K-Number: K111597 · 2011-10-13

ApplicantNuvasive, Inc.
Decision Date2011-10-13
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE STIMULATING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2011-10-13 under 510(k) number K111597. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE STIMULATING ELECTRODE?

DISPOSABLE STIMULATING ELECTRODE is a medical device that received FDA 510(k) clearance on 2011-10-13. The listed applicant is Nuvasive, Inc.. The 510(k) number is K111597.

When did DISPOSABLE STIMULATING ELECTRODE receive FDA 510(k) clearance?

DISPOSABLE STIMULATING ELECTRODE received FDA 510(k) clearance on 2011-10-13, under 510(k) number K111597.

Who is the listed applicant for DISPOSABLE STIMULATING ELECTRODE?

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

What is the FDA product code for DISPOSABLE STIMULATING ELECTRODE?

The FDA product code for DISPOSABLE STIMULATING ELECTRODE is ETN.

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Related Devices (Code: ETN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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