21 CFR 882.4800 — Retractor, Self-Retaining, For Neurosurgery
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4800
Identification
A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | 2 | 43 | 3rd Party |
