510(k) K242741
K242741 is an FDA 510(k) premarket notification submitted by Ace Medical Industry Co., Ltd. for the device "ACE Cannula". The FDA issued a decision of Substantially Equivalent on Jan 8, 2025. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 2025
- Date Received
- Sep 11, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type