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FDA 510(k)

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated

K-Number: K153265 · 2016-01-05

ApplicantNew Deantronics Taiwan , Ltd.
Decision Date2016-01-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K153265. 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 New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated?

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K153265.

When did New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated receive FDA 510(k) clearance?

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated received FDA 510(k) clearance on 2016-01-05, under 510(k) number K153265.

Who is the listed applicant for New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated?

The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated?

The FDA product code for New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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