The following data is part of a premarket notification filed by Citation Medical Corp. with the FDA for The Biopsy Tool.
| Device ID | K941563 |
| 510k Number | K941563 |
| Device Name: | THE BIOPSY TOOL |
| Classification | Biopsy Needle |
| Applicant | CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
| Contact | Edward F Waddell |
| Correspondent | Edward F Waddell CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1994-09-26 |