The following data is part of a premarket notification filed by Conmed Electrosurgery with the FDA for System 7500-b Electrosurgical Unit; Abcflex Probe For Flexible Endoscopy.
| Device ID | K050161 |
| 510k Number | K050161 |
| Device Name: | SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED ELECTROSURGERY 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Contact | Pamela Vetter |
| Correspondent | Pamela Vetter CONMED ELECTROSURGERY 14603 E. FREMONT AVE. Centennial, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-25 |
| Decision Date | 2005-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405043437 | K050161 | 000 |
| 20653405043420 | K050161 | 000 |
| 10653405002987 | K050161 | 000 |