FDA 510(k)

Arc Enterocuff

K-Number: K191330 · 2020-01-31

Decision Date2020-01-31

Product CodeFDA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Arc Enterocuff is a medical device manufactured by Boddingtons Plastics, Ltd.. It received FDA 510(k) clearance on 2020-01-31 under approval number K191330. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arc Enterocuff?

Arc Enterocuff is a medical device that received FDA 510(k) clearance on 2020-01-31. It is manufactured by Boddingtons Plastics, Ltd.. The 510(k) number is K191330.

When was Arc Enterocuff approved by the FDA?

Arc Enterocuff received FDA 510(k) clearance on 2020-01-31, under approval number K191330.

What company makes Arc Enterocuff?

Arc Enterocuff is manufactured by Boddingtons Plastics, Ltd..

What is the FDA product code for Arc Enterocuff?

The FDA product code for Arc Enterocuff is FDA.

Other Devices by Boddingtons Plastics, Ltd.

K162205Arc EndoCuff and Arc EndoCuff Vision K191067Arc Endocuff Glide AEG110 & AEG120

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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.