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FDA 510(k)

SURGITRON RADIOLASE II

K-Number: K042710 · 2005-04-07

ApplicantEllman Int'L, Inc.
Decision Date2005-04-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGITRON RADIOLASE II 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 2005-04-07 under 510(k) number K042710. 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 RADIOLASE II?

SURGITRON RADIOLASE II is a medical device that received FDA 510(k) clearance on 2005-04-07. The listed applicant is Ellman Int'L, Inc.. The 510(k) number is K042710.

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

SURGITRON RADIOLASE II received FDA 510(k) clearance on 2005-04-07, under 510(k) number K042710.

Who is the listed applicant for SURGITRON RADIOLASE II?

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 SURGITRON RADIOLASE II?

The FDA product code for SURGITRON RADIOLASE II 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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