The following data is part of a premarket notification filed by Endotherapeutics with the FDA for Endoport Erocar.
| Device ID | K841716 |
| 510k Number | K841716 |
| Device Name: | ENDOPORT EROCAR |
| Classification | Trocar, Gastro-urology |
| Applicant | ENDOTHERAPEUTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FBQ |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-25 |
| Decision Date | 1984-06-28 |