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FDA 510(k)

SURGITRON IEC II

K-Number: K001986 · 2000-09-27

ApplicantEllman Intl., Inc.
Decision Date2000-09-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGITRON IEC II 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 2000-09-27 under 510(k) number K001986. 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 IEC II?

SURGITRON IEC II is a medical device that received FDA 510(k) clearance on 2000-09-27. The listed applicant is Ellman Intl., Inc.. The 510(k) number is K001986.

When did SURGITRON IEC II receive FDA 510(k) clearance?

SURGITRON IEC II received FDA 510(k) clearance on 2000-09-27, under 510(k) number K001986.

Who is the listed applicant for SURGITRON IEC II?

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 IEC II?

The FDA product code for SURGITRON IEC II is GEI.

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Other records listing Ellman Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013255SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RFK003126BIPOLAR TRIGGER-FLEX PROBEK001407SURGITRON IEC IIK001253SURGITRON IEC IIK992382SURGITRON RADIOLASEK990146SURGITRON

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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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