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FDA 510(k)

NEURALMAS

K-Number: K100992 · 2010-09-24

ApplicantInnovative Surgical Solutions, LLC ("Iss")
Decision Date2010-09-24
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NEURALMAS is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Solutions, LLC ("Iss"). It received FDA 510(k) clearance on 2010-09-24 under 510(k) number K100992. 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 NEURALMAS?

NEURALMAS is a medical device that received FDA 510(k) clearance on 2010-09-24. The listed applicant is Innovative Surgical Solutions, LLC ("Iss"). The 510(k) number is K100992.

When did NEURALMAS receive FDA 510(k) clearance?

NEURALMAS received FDA 510(k) clearance on 2010-09-24, under 510(k) number K100992.

Who is the listed applicant for NEURALMAS?

The FDA 510(k) record lists Innovative Surgical Solutions, LLC ("Iss") as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEURALMAS?

The FDA product code for NEURALMAS is ETN.

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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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