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FDA 510(k)

CERULEAU ELECTROSURGICAL PROBE

K-Number: K101711 · 2010-07-01

ApplicantNuortho Surgical, Inc.
Decision Date2010-07-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERULEAU ELECTROSURGICAL PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Nuortho Surgical, Inc.. It received FDA 510(k) clearance on 2010-07-01 under 510(k) number K101711. 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 CERULEAU ELECTROSURGICAL PROBE?

CERULEAU ELECTROSURGICAL PROBE is a medical device that received FDA 510(k) clearance on 2010-07-01. The listed applicant is Nuortho Surgical, Inc.. The 510(k) number is K101711.

When did CERULEAU ELECTROSURGICAL PROBE receive FDA 510(k) clearance?

CERULEAU ELECTROSURGICAL PROBE received FDA 510(k) clearance on 2010-07-01, under 510(k) number K101711.

Who is the listed applicant for CERULEAU ELECTROSURGICAL PROBE?

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

What is the FDA product code for CERULEAU ELECTROSURGICAL PROBE?

The FDA product code for CERULEAU ELECTROSURGICAL PROBE is GEI.

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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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