Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arc Endocuff Glide AEG110 & AEG120

K-Number: K191067 · 2019-05-30

ApplicantBoddingtons Plastics, Ltd.
Decision Date2019-05-30
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Arc Endocuff Glide AEG110 & AEG120 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 2019-05-30 under 510(k) number K191067. 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 Arc Endocuff Glide AEG110 & AEG120?

Arc Endocuff Glide AEG110 & AEG120 is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Boddingtons Plastics, Ltd.. The 510(k) number is K191067.

When did Arc Endocuff Glide AEG110 & AEG120 receive FDA 510(k) clearance?

Arc Endocuff Glide AEG110 & AEG120 received FDA 510(k) clearance on 2019-05-30, under 510(k) number K191067.

Who is the listed applicant for Arc Endocuff Glide AEG110 & AEG120?

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 Endocuff Glide AEG110 & AEG120?

The FDA product code for Arc Endocuff Glide AEG110 & AEG120 is FED.

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.

K191330Arc EnterocuffK162205Arc EndoCuff and Arc EndoCuff Vision

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.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.

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.

↑