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 a medical device manufactured by Boddingtons Plastics, Ltd.. It received FDA 510(k) clearance on 2019-05-30 under approval 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. It is manufactured by Boddingtons Plastics, Ltd.. The 510(k) number is K191067.
When was Arc Endocuff Glide AEG110 & AEG120 approved by the FDA?
Arc Endocuff Glide AEG110 & AEG120 received FDA 510(k) clearance on 2019-05-30, under approval number K191067.
What company makes Arc Endocuff Glide AEG110 & AEG120?
Arc Endocuff Glide AEG110 & AEG120 is manufactured by Boddingtons Plastics, Ltd..
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 Devices by Boddingtons Plastics, Ltd.
Related Devices (Code: FED)
K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd.
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
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.