The following data is part of a premarket notification filed by Conmed Endoscopic Technologies, Inc. with the FDA for Conmed Axcess Papillotome Models Ax4535, Ax4535fx.
| Device ID | K080946 |
| 510k Number | K080946 |
| Device Name: | CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | CONMED ENDOSCOPIC TECHNOLOGIES, INC. 129 CONCORD RD. Billerica, MA 01821 |
| Contact | Beth Zis |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2008-05-20 |
| Summary: | summary |