FDA 510(k)

VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM

K-Number: K960918 · 1996-10-08

Decision Date1996-10-08

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vidamed, Inc.. It received FDA 510(k) clearance on 1996-10-08 under 510(k) number K960918. 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 VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM?

VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is Vidamed, Inc.. The 510(k) number is K960918.

When did VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM receive FDA 510(k) clearance?

VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM received FDA 510(k) clearance on 1996-10-08, under 510(k) number K960918.

Who is the listed applicant for VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM?

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

What is the FDA product code for VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM?

The FDA product code for VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM is GEI.

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Other records listing Vidamed, Inc. as applicant

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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.