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FDA 510(k)

SURGITRON

K-Number: K990146 · 1999-03-17

ApplicantEllman Intl., Inc.
Decision Date1999-03-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGITRON 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 1999-03-17 under 510(k) number K990146. 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?

SURGITRON is a medical device that received FDA 510(k) clearance on 1999-03-17. The listed applicant is Ellman Intl., Inc.. The 510(k) number is K990146.

When did SURGITRON receive FDA 510(k) clearance?

SURGITRON received FDA 510(k) clearance on 1999-03-17, under 510(k) number K990146.

Who is the listed applicant for SURGITRON?

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?

The FDA product code for SURGITRON 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.

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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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