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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 the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2019-03-05 under 510(k) 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. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K190030.

When did Embrella Endoscopic Distal Attachment receive FDA 510(k) clearance?

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

Who is the listed applicant for Embrella Endoscopic Distal Attachment?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Micro-Tech (Nanjing) Co., Ltd. as applicant

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Related Devices (Code: FED)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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