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FDA 510(k)

SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF

K-Number: K013255 · 2001-11-07

ApplicantEllman Intl., Inc.
Decision Date2001-11-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Intl., Inc.. It received FDA 510(k) clearance on 2001-11-07 under 510(k) number K013255. 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 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF?

SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is Ellman Intl., Inc.. The 510(k) number is K013255.

When did SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF receive FDA 510(k) clearance?

SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF received FDA 510(k) clearance on 2001-11-07, under 510(k) number K013255.

Who is the listed applicant for SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF?

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

What is the FDA product code for SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF?

The FDA product code for SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF is GEI.

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Other records listing Ellman Intl., Inc. as applicant

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Related Devices (Code: GEI)

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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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