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FDA 510(k)

SURGITRON 4.0 DUAL RF S5-IEC

K-Number: K123366 · 2013-07-12

ApplicantEllman International, Inc.
Decision Date2013-07-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGITRON 4.0 DUAL RF S5-IEC is the device name listed in this FDA 510(k) record. The listed applicant is Ellman International, Inc.. It received FDA 510(k) clearance on 2013-07-12 under 510(k) number K123366. 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 SURGITRON 4.0 DUAL RF S5-IEC?

SURGITRON 4.0 DUAL RF S5-IEC is a medical device that received FDA 510(k) clearance on 2013-07-12. The listed applicant is Ellman International, Inc.. The 510(k) number is K123366.

When did SURGITRON 4.0 DUAL RF S5-IEC receive FDA 510(k) clearance?

SURGITRON 4.0 DUAL RF S5-IEC received FDA 510(k) clearance on 2013-07-12, under 510(k) number K123366.

Who is the listed applicant for SURGITRON 4.0 DUAL RF S5-IEC?

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

What is the FDA product code for SURGITRON 4.0 DUAL RF S5-IEC?

The FDA product code for SURGITRON 4.0 DUAL RF S5-IEC is GEI.

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Other records listing Ellman International, Inc. as applicant

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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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