The following data is part of a premarket notification filed by Uro-1, Inc. with the FDA for Vmcore Biopsy Needle.
Device ID | K201650 |
510k Number | K201650 |
Device Name: | VMCore Biopsy Needle |
Classification | Instrument, Biopsy |
Applicant | URO-1, Inc. 111 North Chestnut Street Suite 106 Winston Salem, NC 27101 |
Contact | Thomas Lawson |
Correspondent | Thomas Lawson URO-1, Inc. 111 North Chestnut Street Suite 106 Winston Salem, NC 27101 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-18 |
Decision Date | 2021-01-15 |