The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Urocut Biopsy Needle.
| Device ID | K861267 |
| 510k Number | K861267 |
| Device Name: | UROCUT BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Jane Aoyagi |
| Correspondent | Jane Aoyagi MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-04 |
| Decision Date | 1987-01-20 |