The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Oneport Surgical Trocar System.
| Device ID | K073009 |
| 510k Number | K073009 |
| Device Name: | ONEPORT SURGICAL TROCAR SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
| Contact | Brian Killoran |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-10-25 |
| Decision Date | 2007-12-07 |
| Summary: | summary |