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FDA 510(k)

Endotics

K-Number: K190669 · 2020-01-03

ApplicantEra Endoscopy S.R.L.
Decision Date2020-01-03
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endotics is a medical device manufactured by Era Endoscopy S.R.L.. It received FDA 510(k) clearance on 2020-01-03 under approval number K190669. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endotics?

Endotics is a medical device that received FDA 510(k) clearance on 2020-01-03. It is manufactured by Era Endoscopy S.R.L.. The 510(k) number is K190669.

When was Endotics approved by the FDA?

Endotics received FDA 510(k) clearance on 2020-01-03, under approval number K190669.

What company makes Endotics?

Endotics is manufactured by Era Endoscopy S.R.L..

What is the FDA product code for Endotics?

The FDA product code for Endotics is FDF.

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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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