510(k) K201650
K201650 is an FDA 510(k) premarket notification submitted by Uro-1, Inc. for the device "VMCore Biopsy Needle". The FDA issued a decision of Substantially Equivalent on Jan 15, 2021. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Uro-1, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 15, 2021
- Date Received
- Jun 18, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type
- 510(k)