FDA 510(k)

ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD

K-Number: K971677 · 1997-08-20

ApplicantTransamerican Technologies Intl.

Decision Date1997-08-20

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD is the device name listed in this FDA 510(k) record. The listed applicant is Transamerican Technologies Intl.. It received FDA 510(k) clearance on 1997-08-20 under 510(k) number K971677. 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 ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD?

ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD is a medical device that received FDA 510(k) clearance on 1997-08-20. The listed applicant is Transamerican Technologies Intl.. The 510(k) number is K971677.

When did ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD receive FDA 510(k) clearance?

ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD received FDA 510(k) clearance on 1997-08-20, under 510(k) number K971677.

Who is the listed applicant for ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD?

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

What is the FDA product code for ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD?

The FDA product code for ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD is 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.