The following data is part of a premarket notification filed by Machida America, Inc. with the FDA for Flexible Orthopedic Endoscope Ica-1000.
| Device ID | K841087 |
| 510k Number | K841087 |
| Device Name: | FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 |
| Classification | Arthroscope |
| Applicant | MACHIDA AMERICA, 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 | 1984-03-13 |
| Decision Date | 1984-05-16 |