FDA 510(k)

Electrosurgical disposable grounding pads

K-Number: K160366 · 2016-08-19

Decision Date2016-08-19

Product CodeODR

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Electrosurgical disposable grounding pads is the device name listed in this FDA 510(k) record. The listed applicant is Top-Rank Health Care Co., Ltd.. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K160366. The device is classified under product code ODR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electrosurgical disposable grounding pads?

Electrosurgical disposable grounding pads is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Top-Rank Health Care Co., Ltd.. The 510(k) number is K160366.

When did Electrosurgical disposable grounding pads receive FDA 510(k) clearance?

Electrosurgical disposable grounding pads received FDA 510(k) clearance on 2016-08-19, under 510(k) number K160366.

Who is the listed applicant for Electrosurgical disposable grounding pads?

The FDA 510(k) record lists Top-Rank Health Care Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrosurgical disposable grounding pads?

The FDA product code for Electrosurgical disposable grounding pads is ODR.

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Official Source

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