The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Beamer Aveo Filter Integrated Argon Probe 1.8mm X 160 Cm, Beamer Aveo Filter Integrated Argon Probe 1.8 Mm X 320 Cm, Beamer Aveo Filter Integrated Argon Probe 2.3 Mm X 230 Cm, Beamer Aveo Filter Integrated Argon Probe 2.3 Mm X 320 Cm, Beamer Aveo Fil.
| Device ID | K221945 |
| 510k Number | K221945 |
| Device Name: | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm X 160 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 Mm X 320 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 Mm X 230 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 Mm X 320 Cm, Beamer AVEO FIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Conmed Corporation 11311 Concept Blvd Largo, FL 33773 |
| Contact | Kavita Amin |
| Correspondent | Kavita Amin Conmed Corporation 11311 Concept Blvd Largo, FL 33773 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405987332 | K221945 | 000 |
| 30653405987240 | K221945 | 000 |
| 30653405987233 | K221945 | 000 |
| 30653405987226 | K221945 | 000 |
| 30653405987219 | K221945 | 000 |
| 30653405987202 | K221945 | 000 |