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FDA 510(k)

GIVEN ELECTROSURGICAL NEEDLE

K-Number: K082584 · 2009-10-28

ApplicantTripps Court Enterprises, Inc.
Decision Date2009-10-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GIVEN ELECTROSURGICAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Tripps Court Enterprises, Inc.. It received FDA 510(k) clearance on 2009-10-28 under 510(k) number K082584. 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 GIVEN ELECTROSURGICAL NEEDLE?

GIVEN ELECTROSURGICAL NEEDLE is a medical device that received FDA 510(k) clearance on 2009-10-28. The listed applicant is Tripps Court Enterprises, Inc.. The 510(k) number is K082584.

When did GIVEN ELECTROSURGICAL NEEDLE receive FDA 510(k) clearance?

GIVEN ELECTROSURGICAL NEEDLE received FDA 510(k) clearance on 2009-10-28, under 510(k) number K082584.

Who is the listed applicant for GIVEN ELECTROSURGICAL NEEDLE?

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

What is the FDA product code for GIVEN ELECTROSURGICAL NEEDLE?

The FDA product code for GIVEN ELECTROSURGICAL NEEDLE 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.

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