The following data is part of a premarket notification filed by Endotherapeutics with the FDA for Endoport 5mm.
| Device ID | K852031 |
| 510k Number | K852031 |
| Device Name: | ENDOPORT 5MM |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City, CA 94063 |
| Contact | Frederic H Moll |
| Correspondent | Frederic H Moll ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City, CA 94063 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-08-13 |