ACE Cannula
K-Number: K242741 · 2025-01-08
ApplicantAce Medical Industry Co., Ltd.
Decision Date2025-01-08
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ACE Cannula is a medical device manufactured by Ace Medical Industry Co., Ltd.. It received FDA 510(k) clearance on 2025-01-08 under approval number K242741. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ACE Cannula?
ACE Cannula is a medical device that received FDA 510(k) clearance on 2025-01-08. It is manufactured by Ace Medical Industry Co., Ltd.. The 510(k) number is K242741.
When was ACE Cannula approved by the FDA?
ACE Cannula received FDA 510(k) clearance on 2025-01-08, under approval number K242741.
What company makes ACE Cannula?
ACE Cannula is manufactured by Ace Medical Industry Co., Ltd..
What is the FDA product code for ACE Cannula?
The FDA product code for ACE Cannula is FMI.
Related Devices (Code: FMI)
K162516BD Pen NeedleBecton, Dickinson and Company
K160532Greiner HoldexGreiner Bio-One Na, Inc.
K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc.
K151090CPL Insulin Pen NeedleCpl Co., Ltd.
K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.
K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.
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.