510(k) K180037
K180037 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Beacon EUS Access System". The FDA issued a decision of Substantially Equivalent on April 26, 2018. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Covidien, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2018
- Date Received
- January 5, 2018
- 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