The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Arthroscope.
| Device ID | K843208 |
| 510k Number | K843208 |
| Device Name: | ACUFEX ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | ACUFEX MICROSURGICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-15 |
| Decision Date | 1984-09-11 |