Part 888 Subpart B—Diagnostic Devices
FDA submissions for Part 888 Subpart B—Diagnostic Devices in the Orthopedic (OR) review panel, including product codes and regulations.
Section range: §§ 888.1100–888.1600
CFR Part: 888
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| HRX | Arthroscope | 888.1100 | 2 | 681 |
| NBH | Accessories, Arthroscopic | 888.1100 | 1 | 2 |
| NGR | Tester, Stiffness, Cartilage, Arthroscopic | 888.1100 | 2 | 2 |
| PPR | Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures | 888.1100 | 2 | 0 |
| LBB | Dynamometer, Ac-Powered | 888.1240 | 2 | 36 |
| HRW | Dynamometer, Nonpowered | 888.1250 | 1 | 12 |
| KQX | Goniometer, Ac-Powered | 888.1500 | 1 | 33 |
| NKI | Goniometer With Electrodes | 888.1500 | 2 | 1 |
| KQW | Goniometer, Nonpowered | 888.1520 | 1 | 13 |
| LZE | Isometer | 888.1520 | 1 | 1 |
| QGQ | Bone Indentation Device | 888.1600 | 2 | 3 |