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FDA 510(k)

THE GOLDEN TIP ELECTRO-SURGICAL PROBE

K-Number: K984275 · 1999-02-01

ApplicantAmada Surgical
Decision Date1999-02-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE GOLDEN TIP ELECTRO-SURGICAL PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Amada Surgical. It received FDA 510(k) clearance on 1999-02-01 under 510(k) number K984275. 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 THE GOLDEN TIP ELECTRO-SURGICAL PROBE?

THE GOLDEN TIP ELECTRO-SURGICAL PROBE is a medical device that received FDA 510(k) clearance on 1999-02-01. The listed applicant is Amada Surgical. The 510(k) number is K984275.

When did THE GOLDEN TIP ELECTRO-SURGICAL PROBE receive FDA 510(k) clearance?

THE GOLDEN TIP ELECTRO-SURGICAL PROBE received FDA 510(k) clearance on 1999-02-01, under 510(k) number K984275.

Who is the listed applicant for THE GOLDEN TIP ELECTRO-SURGICAL PROBE?

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

What is the FDA product code for THE GOLDEN TIP ELECTRO-SURGICAL PROBE?

The FDA product code for THE GOLDEN TIP ELECTRO-SURGICAL PROBE is GEI.

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Official Source

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