Button Loop
K-Number: K202291 · 2021-01-08
Decision Date2021-01-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Button Loop is a medical device manufactured by Yunyi (Beijing) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-01-08 under approval number K202291. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Button Loop?
Button Loop is a medical device that received FDA 510(k) clearance on 2021-01-08. It is manufactured by Yunyi (Beijing) Medical Device Co., Ltd.. The 510(k) number is K202291.
When was Button Loop approved by the FDA?
Button Loop received FDA 510(k) clearance on 2021-01-08, under approval number K202291.
What company makes Button Loop?
Button Loop is manufactured by Yunyi (Beijing) Medical Device Co., Ltd..
What is the FDA product code for Button Loop?
The FDA product code for Button Loop is MBI.
Other Devices by Yunyi (Beijing) Medical Device Co., Ltd.
Related Devices (Code: MBI)
K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.
K162198GFS UltimateParcus Medical, LLC
K162386KATOR Suture AnchorKator, LLC
K161033AFX Femoral Implant With InserterCayenne Medical, Inc.
K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC
K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL
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.