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FDA 510(k)

SURGI-MAX

K-Number: K061174 · 2006-06-28

ApplicantEllman Int'L, Inc.
Decision Date2006-06-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGI-MAX is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Int'L, Inc.. It received FDA 510(k) clearance on 2006-06-28 under 510(k) number K061174. 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 SURGI-MAX?

SURGI-MAX is a medical device that received FDA 510(k) clearance on 2006-06-28. The listed applicant is Ellman Int'L, Inc.. The 510(k) number is K061174.

When did SURGI-MAX receive FDA 510(k) clearance?

SURGI-MAX received FDA 510(k) clearance on 2006-06-28, under 510(k) number K061174.

Who is the listed applicant for SURGI-MAX?

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

What is the FDA product code for SURGI-MAX?

The FDA product code for SURGI-MAX is GEI.

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Other records listing Ellman Int'L, 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.

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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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