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FDA 510(k)

Embrella Endoscopic Distal Attachment

K-Number: K190030 · 2019-03-05

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2019-03-05
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Embrella Endoscopic Distal Attachment is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2019-03-05 under approval number K190030. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Embrella Endoscopic Distal Attachment?

Embrella Endoscopic Distal Attachment is a medical device that received FDA 510(k) clearance on 2019-03-05. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K190030.

When was Embrella Endoscopic Distal Attachment approved by the FDA?

Embrella Endoscopic Distal Attachment received FDA 510(k) clearance on 2019-03-05, under approval number K190030.

What company makes Embrella Endoscopic Distal Attachment?

Embrella Endoscopic Distal Attachment is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Embrella Endoscopic Distal Attachment?

The FDA product code for Embrella Endoscopic Distal Attachment is FED.

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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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