The following data is part of a premarket notification filed by Endotherapeutics with the FDA for Mod. Endoport Single-use Trocar And Sleeve.
| Device ID | K860103 |
| 510k Number | K860103 |
| Device Name: | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE |
| Classification | Endoscope, Ac-powered And Accessories |
| Applicant | ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City, CA 94063 |
| Contact | Russell Thompson |
| Correspondent | Russell Thompson ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City, CA 94063 |
| Product Code | GCP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-10 |
| Decision Date | 1986-02-12 |