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FDA 510(k)

TRIDENT RESECTION ABLATOR

K-Number: K033748 · 2003-12-15

ApplicantLinvatec Corp.
Decision Date2003-12-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIDENT RESECTION ABLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2003-12-15 under 510(k) number K033748. 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 TRIDENT RESECTION ABLATOR?

TRIDENT RESECTION ABLATOR is a medical device that received FDA 510(k) clearance on 2003-12-15. The listed applicant is Linvatec Corp.. The 510(k) number is K033748.

When did TRIDENT RESECTION ABLATOR receive FDA 510(k) clearance?

TRIDENT RESECTION ABLATOR received FDA 510(k) clearance on 2003-12-15, under 510(k) number K033748.

Who is the listed applicant for TRIDENT RESECTION ABLATOR?

The FDA 510(k) record lists Linvatec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIDENT RESECTION ABLATOR?

The FDA product code for TRIDENT RESECTION ABLATOR is GEI.

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Other records listing Linvatec Corp. 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

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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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