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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 a medical device manufactured by Shining World Health Care Co., Ltd.. It received FDA 510(k) clearance on 2022-01-28 under approval 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. It is manufactured by Shining World Health Care Co., Ltd.. The 510(k) number is K213317.

When was ShinEvac Smoke Evacuation Pencil approved by the FDA?

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

What company makes ShinEvac Smoke Evacuation Pencil?

ShinEvac Smoke Evacuation Pencil is manufactured by Shining World Health Care Co., Ltd..

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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