21 CFR 882.4525 — Instrument, Microsurgical
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4525
Identification
A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZX | Instrument, Microsurgical | 1 | 13 | |
| OJG | Neurological Tray | 1 | 0 |
