510(k) K230909
K230909 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)". The FDA issued a decision of Substantially Equivalent on May 30, 2023. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Cook Ireland, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2023
- Date Received
- March 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biopsy Needle
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type