510(k) K191472
K191472 is an FDA 510(k) premarket notification submitted by Ushare Medical, Inc. for the device "Biopsy Needle". The FDA issued a decision of Substantially Equivalent on January 29, 2020. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Ushare Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2020
- Date Received
- June 3, 2019
- 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