21 CFR 888.4300 — Gauge, Depth
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4300
Identification
A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.
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 § 888.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HTJ | Gauge, Depth | 1 | 4 |
