21 CFR 876.5450 — Dilator, Rectal
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5450
Identification
A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.
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 § 876.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FFP | Dilator, Rectal | 1 | 5 | |
| PSJ | Rectal Dilator Kit | 1 | 0 |
