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FDA 510(k)

ShinEvac Smoke Evacuation Pencil

K-Number: K213317 · 2022-01-28

ApplicantShining World Health Care Co., Ltd.
Decision Date2022-01-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ShinEvac Smoke Evacuation Pencil is the device name listed in this FDA 510(k) record. The listed applicant is Shining World Health Care Co., Ltd.. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K213317. 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 ShinEvac Smoke Evacuation Pencil?

ShinEvac Smoke Evacuation Pencil is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Shining World Health Care Co., Ltd.. The 510(k) number is K213317.

When did ShinEvac Smoke Evacuation Pencil receive FDA 510(k) clearance?

ShinEvac Smoke Evacuation Pencil received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213317.

Who is the listed applicant for ShinEvac Smoke Evacuation Pencil?

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

What is the FDA product code for ShinEvac Smoke Evacuation Pencil?

The FDA product code for ShinEvac Smoke Evacuation Pencil 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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