The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for (roth)spiral Rotating Prostatic Biopsy Needle.
| Device ID | K863385 |
| 510k Number | K863385 |
| Device Name: | (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE |
| Classification | Components, Wheelchair |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Frederick D Roemer |
| Correspondent | Frederick D Roemer COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | KNN |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-11-04 |