The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Endoscopic Electrosurgical Fiberoptic Probe.
| Device ID | K861331 |
| 510k Number | K861331 |
| Device Name: | ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE |
| Classification | Laser For Gastro-urology Use |
| Applicant | TRIMEDYNE, INC. 1815 EAST CARNEGIE AVE. Santa Ana, CA 92705 |
| Contact | Hussein, Ph.d. |
| Correspondent | Hussein, Ph.d. TRIMEDYNE, INC. 1815 EAST CARNEGIE AVE. Santa Ana, CA 92705 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-09 |
| Decision Date | 1986-08-07 |