The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Enteroscope.
| Device ID | K840722 |
| 510k Number | K840722 |
| Device Name: | ENTEROSCOPE |
| Classification | Enteroscope And Accessories |
| Applicant | TRIMEDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FDA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-17 |
| Decision Date | 1984-06-07 |