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FDA 510(k)

Arc Enterocuff

K-Number: K191330 · 2020-01-31

ApplicantBoddingtons Plastics, Ltd.
Decision Date2020-01-31
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Arc Enterocuff is the device name listed in this FDA 510(k) record. The listed applicant is Boddingtons Plastics, Ltd.. It received FDA 510(k) clearance on 2020-01-31 under 510(k) 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. The listed applicant is Boddingtons Plastics, Ltd.. The 510(k) number is K191330.

When did Arc Enterocuff receive FDA 510(k) clearance?

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

Who is the listed applicant for Arc Enterocuff?

The FDA 510(k) record lists Boddingtons Plastics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arc Enterocuff?

The FDA product code for Arc Enterocuff is FDA.

Other records listing Boddingtons Plastics, Ltd. as applicant

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.

K191067Arc Endocuff Glide AEG110 & AEG120K162205Arc EndoCuff and Arc EndoCuff Vision

Related Devices (Code: FDA)

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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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