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 and Arc EndoCuff Vision

K-Number: K162205 · 2016-12-09

ApplicantBoddingtons Plastics, Ltd.
Decision Date2016-12-09
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Arc EndoCuff and Arc EndoCuff Vision 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 2016-12-09 under 510(k) number K162205. 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 and Arc EndoCuff Vision?

Arc EndoCuff and Arc EndoCuff Vision is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Boddingtons Plastics, Ltd.. The 510(k) number is K162205.

When did Arc EndoCuff and Arc EndoCuff Vision receive FDA 510(k) clearance?

Arc EndoCuff and Arc EndoCuff Vision received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162205.

Who is the listed applicant for Arc EndoCuff and Arc EndoCuff Vision?

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 and Arc EndoCuff Vision?

The FDA product code for Arc EndoCuff and Arc EndoCuff Vision 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 EnterocuffK191067Arc Endocuff Glide AEG110 & AEG120

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.

↑