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 a medical device manufactured by Boddingtons Plastics, Ltd.. It received FDA 510(k) clearance on 2016-12-09 under approval 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. It is manufactured by Boddingtons Plastics, Ltd.. The 510(k) number is K162205.
When was Arc EndoCuff and Arc EndoCuff Vision approved by the FDA?
Arc EndoCuff and Arc EndoCuff Vision received FDA 510(k) clearance on 2016-12-09, under approval number K162205.
What company makes Arc EndoCuff and Arc EndoCuff Vision?
Arc EndoCuff and Arc EndoCuff Vision is manufactured by Boddingtons Plastics, Ltd..
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.
Related Clinical Trials
Other Devices by Boddingtons Plastics, Ltd.
Related Devices (Code: FED)
K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.
K160846AmplifEYEMedivators, Inc.
K160861Proxis Ureteral Access SheathC.R. Bard, Inc.
K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd.
K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated
K181811ReTrace Ureteral Access SheathColoplast A/S
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.